Depression Clinical Trial
— THRIVEOfficial title:
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries
Status | Recruiting |
Enrollment | 12500 |
Est. completion date | July 31, 2028 |
Est. primary completion date | July 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria Each patient must meet all of the following criteria: 1. Aged 18 years or older 2. Undergoing elective non-cardiac surgery expected to last = 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device) Exclusion Criteria Patients will not be enrolled if any of the following criteria are met: 1. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option) 2. Pregnancy (based on patient report or positive test on the day of surgery) 3. Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date 4. Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report 5. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring). 6. Locally approved, written protocol mandating a particular anesthetic technique 7. History of intraoperative awareness during general anesthesia based on patient self-report 8. Planned postoperative intubation 9. Current incarceration |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | UVA Health | Charlottesville | Virginia |
United States | Yale School of Medicine | New Haven | Connecticut |
United States | Weill Cornell Medicine | New York | New York |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Wake Forest | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Patient-Centered Outcomes Research Institute, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Daily step count at baseline - number of steps per day | 1 - 7 days prior to surgery | |
Other | Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery. | Daily step count at baseline - number of steps per day | 1 - 7 days prior to surgery | |
Other | Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery. | Daily step count at baseline - number of steps per day | 1 - 7 days prior to surgery | |
Other | Daily step count as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery | |
Other | Daily step count as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery | |
Other | Daily step count as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 7 - 10 days after surgery | |
Other | Daily step count as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery | |
Other | Daily step count as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery | |
Other | Daily step count as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day | 30 - 34 days after surgery | |
Other | Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery | |
Other | Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery | |
Other | Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery. | Daily standing hours: defined as standing hours per day | 1 - 7 days prior to surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
7 - 10 days after surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
7 - 10 days after surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
7 - 10 days after surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
30 - 34 days after surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
30 - 34 days after surgery | |
Other | Daily standing hours as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device.
Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day |
30 - 34 days after surgery | |
Other | Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery | |
Other | Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery | |
Other | Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Total sleep time defined as minutes of total sleep time per day | 1 - 7 days prior to surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
7 - 10 days after surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
7 - 10 days after surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
7 - 10 days after surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
30 - 34 days after surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
30 - 34 days after surgery | |
Other | Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day |
30 - 34 days after surgery | |
Other | Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery | |
Other | Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery | |
Other | Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery. | Sleep onset latency: defined as minutes of sleep onset latency per day | 1 - 7 days prior to surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
7 - 10 days after surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
7 - 10 days after surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
7 - 10 days after surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
30 - 34 days after surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
30 - 34 days after surgery | |
Other | Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day |
30 - 34 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Wake after sleep onset: defined as minutes of wake after sleep onset | 1 - 7 days prior to surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
7 - 10 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
7 - 10 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
7 - 10 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
30 - 34 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
30 - 34 days after surgery | |
Other | Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset |
30 - 34 days after surgery | |
Other | Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery | |
Other | Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery | |
Other | Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery. | Sleep efficiency: defined as % sleep efficiency (ranging from 0-100) | 1 - 7 days prior to surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
7 - 10 days after surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
7 - 10 days after surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
7 - 10 days after surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
30 - 34 days after surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
30 - 34 days after surgery | |
Other | Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable
Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100) |
30 - 34 days after surgery | |
Other | Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery | |
Other | Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery | |
Other | Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery. | Midpoint of sleep: defined as midpoint of sleep (time) | 1 - 7 days prior to surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
7 - 10 days after surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
7 - 10 days after surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
7 - 10 days after surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
30 - 34 days after surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
30 - 34 days after surgery | |
Other | Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery. | Measurement of outcomes will be median values measured on their wearable device
Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time) |
30 - 34 days after surgery | |
Primary | Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
baseline to day 1 | |
Primary | Quality of Recovery-15 score on POD1 after minor inpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
baseline to day 1 | |
Primary | Quality of Recovery-15 score on POD1 after Outpatient surgery | We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
baseline to day 1 | |
Primary | Incidence of unintended intraoperative awareness with recall on POD1 or POD30 | Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA. | 30 days | |
Secondary | Quality of Recovery-15 score on POD0 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD0 minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD0 outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD2 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD2 after minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD2 after outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD7 after major inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD7 after minor inpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Quality of Recovery-15 score on POD7 after outpatient surgery | We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed. |
7 days | |
Secondary | Incidence of delirium on POD0 after major inpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery. | 1 day | |
Secondary | Incidence of delirium on POD0 after minor surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery. | 1 day | |
Secondary | Incidence of delirium on POD1 after major inpatient | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery. | 1 day | |
Secondary | Incidence of delirium on POD1 after minor inpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery. | 1 day | |
Secondary | Incidence of delirium on POD1 after outpatient surgery | Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery. | 1 day | |
Secondary | Days alive and at-home at POD30 after major inpatient surgery | The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded. | 30 days | |
Secondary | Days alive and at-home at POD30 after minor inpatient surgery | The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded. | 30 days | |
Secondary | EQ-5D-5L Quality of life on POD30 after major inpatient surgery | EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
30 days | |
Secondary | EQ-5D-5L Quality of life on POD30 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
30 days | |
Secondary | EQ-5D-5L Quality of life on POD30 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
30 days | |
Secondary | EQ-5D-5L Quality of life on POD90 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
90 days | |
Secondary | EQ-5D-5L Quality of life on POD90 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
90 days | |
Secondary | EQ-5D-5L Quality of life on POD90 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
90 days | |
Secondary | EQ-5D-5L Quality of life on POD180 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
180 days | |
Secondary | EQ-5D-5L Quality of life on POD180 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
180 days | |
Secondary | EQ-5D-5L Quality of life on POD180 after outpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
180 days | |
Secondary | EQ-5D-5L Quality of life on POD365 after major inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
365 days | |
Secondary | EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
365 days | |
Secondary | EQ-5D-5L Quality of life on POD365 after out patient surgery | Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf |
365 days | |
Secondary | Bauer Questionnaire - Patient satisfaction with anesthesia at POD2 | Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care:
"very satisfied", "satisfied", "dissatisfied", or "very dissatisfied" |
2 days | |
Secondary | Respiratory failure on POD0 | Respiratory failure on POD0 | 1 day | |
Secondary | kidney injury on POD7 | kidney injury on POD7 | 7 days | |
Secondary | all-cause mortality at POD30 | all-cause mortality at POD30 | 30 days | |
Secondary | all-cause mortality at POD90 | all-cause mortality at POD90 | 90 days | |
Secondary | intraoperative hypotension | intraoperative hypotension | 90 days | |
Secondary | moderate to severe intraoperative patient movement | moderate to severe intraoperative patient movement | 90 days | |
Secondary | unplanned admission after outpatient surgery in an ambulatory setting | unplanned admission after outpatient surgery in an ambulatory setting | 90 days | |
Secondary | Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR | Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR | 90 days | |
Secondary | Incidence of malignant hyperthermia as reported in the EHR | Incidence of malignant hyperthermia as reported in the EHR | 90 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have major inpatient surgery. | functional status | Baseline | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have minor inpatient surgery. | functional status | Baseline | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have outpatient surgery. | functional status | Baseline | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery. | functional status | 30 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery. | functional status | 30 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery. | functional status | 30 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery. | functional status | 90 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery. | functional status | 90 days | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery. | functional status | 90 days |
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