Delirium Clinical Trial
— SHARPOfficial title:
Shaping Anesthetic Techniques to Reduce Post-Operative Delirium
NCT number | NCT03133845 |
Other study ID # | IRB00113655 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | May 25, 2020 |
Verified date | June 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.
Status | Completed |
Enrollment | 218 |
Est. completion date | May 25, 2020 |
Est. primary completion date | May 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients age 65 and over. - Patients undergoing lumbar fusion performed by Dr. Charles Edwards II, Dr. Charles Edwards, Dr. Clayton Dean , or Dr. Justin Park at Mercy Medical Center. - Expected length of surgery <3 hours. - Ability to understand study procedures and to comply with them for the entire length of the study Exclusion Criteria: - Contradictions to spinal anesthesia (severe aortic stenosis, anti-coagulant or antiplatelet medications, other) - Body mass index > 40 kg/m2 - prior lumbar fusion from L2-L5 in entirety - Communication issues precluding delirium assessment or sedation - Dementia or mini-mental status exam score < 24 - Psychiatric disease that would preclude cooperation with sedation with spinal anesthesia - Any other reason that the attending anesthesiologist or surgeon feels that clinical circumstances dictate a strong preference for either spinal or general anesthesia. - Inability or unwillingness of individual or legal guardian/representative to give written informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Mercy Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Mercy Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of delirium | The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days. | First 3 postoperative days | |
Secondary | Assessment of cognitive status at 3 months using the Verbal Fluency Test | The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline. | 3 months after surgery | |
Secondary | Assessment of cognitive status at 1 year using the Verbal Fluency test. | The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline. | 1 year after surgery | |
Secondary | Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test. | At 3 months, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score. | 3 months after surgery | |
Secondary | Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test. | At 1 year, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score. | 1 year after surgery | |
Secondary | Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12) | This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. | 3 months after surgery | |
Secondary | Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12) | This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. | 1 year after surgery | |
Secondary | Assessment of functional status at 3 months using the Oswestry Disability Index (ODI) | This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the baseline score. | 3 months after surgery | |
Secondary | Assessment of functional status at 1 year using the Oswestry Disability Index (ODI) | This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | |
Secondary | Assessment of cognitive status at 3 months using Trail Making Test | This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the score obtained at baseline. | 3 months after surgery | |
Secondary | Assessment of cognitive status at 1 year using Trail Making Test | This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the scores obtained at baseline and 1 year after surgery. | 1 year after surgery | |
Secondary | Assessment of cognitive status at 3 months using the Digit Span | The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the score obtained at baseline. | 3 months after surgery | |
Secondary | Assessment of cognitive status at 1 year using the Digit Span | The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | |
Secondary | Assessment of the cognitive status at 3 months using the Mini Mental Status Exam | The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. This score will be compared to the score obtained at baseline. | 3 months after surgery | |
Secondary | Assessment of the cognitive status at 1 year using the Mini Mental Status Exam | The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. The score obtained will be compared to the scores obtained at baseline and 3 months after surgery. | 1 year after surgery | |
Secondary | Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS) | The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment. | 3 months after surgery | |
Secondary | Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS) | The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment. | 1 year after surgery | |
Secondary | Maximum severity of delirium during hospital stay | The patient will be assessed for delirium using the maximum total score on the Delirium Rating Scale-Revised 1998. The scale range is 0-32, with 0 being low delirium severity and 32 being high delirium severity. | Through the end of hospitalization, up to 3 months | |
Secondary | Number of participants with hospital readmissions within 30 days of discharge | Hospital readmissions will be measured. | 30 days from hospital discharge | |
Secondary | Number of participants with emergency room visit within 30 days of hospital discharge | Emergency Room Visits will be measured. | 30 days from hospital discharge | |
Secondary | Number of days in hospital after surgery | The number of days in hospital after surgery will be calculated for each patient. | Immediately after surgery until discharge, up to 3 months | |
Secondary | Last pain score in the post-anesthesia care unit | The last pain score on the NRS pain scale of 0-10 taken in the post-anesthesia care unit by the post-anesthesia care unit staff. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | Immediately before leaving the post-anesthesia care unit, up to 1 day | |
Secondary | Total morphine equivalents of opioids given in the post-anesthesia care unit | The total amount of opioids given to each patient in the post-anesthesia care unit will be converted to morphine equivalents for each patient. | During post-anesthesia care unit stay, up to 1 week | |
Secondary | Time first opioid given in the post-anesthesia care unit | The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit. | The time the first opioid medication is given to the patient in the post-anesthesia care unit, up to 1 week | |
Secondary | Last pain score prior to hospital discharge | The last pain score recorded for each participant on the NRS pain scale of 0-10. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | Immediately before hospital discharge | |
Secondary | Total amount of morphine equivalents during hospital stay | The total amount of morphine equivalents will be measure for each participants hospital stay. The amount measured will be pro-rated tp the participant's length of stay. | Duration of the hospital length of stay, up to 3 months | |
Secondary | The average pain score at 3 month follow-up | The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 3 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | one week prior to end of 3 month follow-up | |
Secondary | The average pain score at 12 month follow-up | The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 12 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain. | one week prior to end of 12 month follow-up | |
Secondary | Number of days with delirium | The number of days with delirium will measured for each participant during the length of the hospital stay for each participant. | Duration of the hospital stay, up to 3 months |
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