High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

Post-Operative Confusion Clinical Trial

Official title:

High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374356
• Other study ID #: HS23755 B2020:026
• Status: Recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: University of Manitoba
• Contact: Stephen E Kowalski, MD
• Phone: 2042273626
• Email: sekowalski[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study to determine if enough patients undergoing elective or urgent cardiac surgery, can be enrolled in a study where patients are randomized to receive high spinal anesthesia as an adjunct to general anesthesia for their cardiac surgery. The primary clinical outcome will be the incidence of post-operative delirium.

Description:

Intervention

Patients will be randomized to either general anesthesia (GA) or HSA + GA.

1. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).

2. Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated.

3. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.

4. Intraoperative physiological data (mean blood pressure, end-tidal anesthetic gas concentrations, BIS score) will be recorded and downloaded to a laptop computer using the Trend Face Solo acquisition system for subsequent analysis.

5. The routine postoperative care map for the postoperative cardiac intensive care unit (ICCS) will be followed.

6. All patients will be assessed by the study investigator for presence/absence of delirium on postoperative days 1,2 & 3, as well as routine nursing assessment by the delirium assessment tool CAM-ICU, routinely done by nursing staff. Chart reviews will be conducted to confirm any additional incidence of delirium.

7. All patients will be contacted at one and three months after surgery and asked to complete a ten-minute survey (Postop QoR-15 questionnaire) assessing their quality of recovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (>18 years old) patients

• Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass

Exclusion Criteria:

• Contraindications to spinal anesthesia such as active anticoagulation, clopidogrel within 7 days of surgery, ticagrelor within 3 days of surgery and all other contraindications to lumbar puncture

• Pre-existing psychiatric diagnoses such as schizophrenia or manic-depressive disorder

• Complex aortic surgery (> hemi-arch repair, descending thoracic surgery)

• Difficult airway requiring an awake intubation

• BMI > 50

Related Conditions & MeSH terms

• Confusion
• Delirium
• Post-Operative Confusion

Intervention

Drug:
• Intrathecal bupivacaine and morphine
Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).

Locations

Country	Name	City	State
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of intraoperative extubation	Incidence of extubation in the operating room (%)	Day of surgery
Other	Duration of ICU intubation	Duration of ICU intubation in hours for those patients brought intubated to the ICU	Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Other	Post-operative pain scores at rest	VAS pain scores (visual analog score) (0 is no pain, 10 is the worst pain possible) at rest for 3 days post-operatively.	Post-operative day 1 until post-operative day 3
Other	Post-operative pain scores with deep breathing	VAS pain scores (0 is no pain, 10 is the worst pain possible) with deep breathing for 3 days post-operatively.	Post-operative day 1 until post-operative day 3
Other	Post-operative hydromorphone administered	Total hydromorphone use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Hydromorphone totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator).	Day of surgery until post-operative day 3
Other	Post-operative fentanyl administered	Total fentanyl use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Fentanyl totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator).	Day of surgery until post-operative day 3
Other	Post-operative codeine administered	Total codeine use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Codeine totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator).	Day of surgery until post-operative day 3
Other	Post-operative morphine administered	Total morphine use, in milligrams, including intravenous and oral administration will be recorded for the first 48 hours postoperatively.	Day of surgery until post-operative day 3
Other	Intraoperative hypotension	Length of time (mins) mean arterial blood pressure is less than 55 mmHg	Day of surgery
Other	Intraoperative end-tidal gas concentration	Mean intraoperative end-tidal gas concentration (%)	Day of surgery
Other	Intraoperative depth of anesthesia	Mean intraoperative bispectral index (BIS). The BIS scale range is from 0 to 100, with 0 representing no measurable electrical brain activity and 100 the electrical activity of an awake, conscious individual. Currently BIS scores are attempted to be kept between 20 and 40 during surgery to ensure adequate depth of anesthesia.	Day of surgery
Other	Intraoperative sufentanil administered	Total dose of intraoperative sufentanil in micrograms. Sufentanil dosage will be converted to morphine equivalents using the MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator)	Day of surgery
Other	Intraoperative hydromorphone administered	Total dose of intraoperative hydromorphone in milligrams. Hydromorphone doses will be converted to morphine equivalents using the MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator)	Day of surgery
Other	Intraoperative midazolam administered	Total dose of intraoperative midazolam in milligrams.	Day of surgery
Other	Intraoperative ketamine administered	Total dose of intraoperative ketamine in milligrams	Day of surgery
Other	Intraoperative glucose level	Highest intraoperative glucose level in millimoles per litre.	Day of surgery
Other	Intraoperative insulin administered	Total intraoperative insulin administered in units of insulin.	Day of surgery
Other	Total RBC utilization	Total RBC administered (units) both intraoperatively, and postoperatively until post-operative day 3..	Day of surgery until post-operative day 3
Other	Total platelet utilization	Total units of platelets administered (adult doses of platelets ) both intraoperatively, and postoperatively until post-operative day 3	Day of surgery until post-operative day 3
Other	Return to OR for bleeding	Incidence of a return to the operating room for bleeding (%)	Day of surgery until post-operative day 3
Other	Vasopressor (norepinephrine or phenylephrine or vasopressin) use at 12 hours	Incidence of use of either norepinephrine, phenylephrine or vasopressin at 12 hours postoperatively (%)	First 12 hours postoperatively
Other	Vasopressor (norepinephrine, phenylephrine or vasopressin) use at 24 hours	Incidence of use of norepinephrine, phenylephrine or vasopressin administered at 24 hours postoperatively (%)	12 to 24 hours postoperatively
Other	Vasopressor (norepinephrine, phenylephrine or vasopressin) use at >24 hours	Incidence of norepinephrine, phenylephrine or vasopressin use longer than 24 hours postoperatively (%)	Post-operative day 2 to post-operative day 7
Other	Incidence of re-intubation	Incidence of re-intubation postoperatively (%) from day of surgery to discharge from hospital	Day of surgery until 14 days post-operatively or discharge from hospital, whichever occurs first.
Other	ICU re-admission	Incidence of re-admission to ICU for any reason from post-operative day 2 to post-operative day 14 or discharge from hospital (%)	Post-operative day 2 until post-operative day 14 or discharge from hospital, whichever occurs first.
Other	Hospital length of stay	Postoperative hospital length of stay in days	Time (days) in hospital from post-operative 1 to 30 (or through discharge from hospital)
Other	ICU length of stay	Postoperative ICU length of stay in days	Time (days) in ICU from post-operative day 1 to 5 (or through discharge from hospital)
Other	Major medical complications	Incidence of major medical complications (%) defined as one or more of: a. Atrial fibrillation b. Pneumonia c. Acute kidney injury (defined as a doubling of pre-operative creatinine) d. Need for dialysis e. Wound infection f. Stroke g. Other	Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Other	Post-operative quality of recovery - one month	Postoperative quality of life score (Postop QoR-15) will be used to assess quality of recovery at one month postoperatively. The Post QoR-15 scale ranges from 0 to 150, with 0 representing the poorest quality of recovery and 150 the best quality of recovery.	30 days post surgery
Other	Post-operative quality of recovery - three months	Postoperative quality of life score (Postop QoR-15) will be used to assess quality of recovery at three month postoperatively. The Post QoR-15 scale ranges from 0 to 150, with 0 representing the poorest quality of recovery and 150 the best quality of recovery.	90 days post surgery
Other	Post-operative creatinine level	Highest post-operative creatinine (umol/l) level recorded during hospital stay.	Day of surgery until 14 days post-operatively or hospital discharge, whichever occurs first.
Primary	Recruitment rate	Mean number of patients recruited per week) (n)	One year
Primary	Protocol adherence measure - establishment of spinal anesthetic	In order to assess protocol adherence (%), in patients randomized to spinal anesthesia, an 80% success rate in establishing a spinal anesthetic will be considered as protocol adherence.	Day of surgery
Primary	Protocol adherence measure - completion of delirium assessments	In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence.	Day of surgery until five days post-operatively
Secondary	Early incidence of post-operative delirium	Duration of delirium (days) as assessed by the number of positive Confusion Assessment Method (CAM) as assessed by study investigator	Day of surgery until five days post-operatively
Secondary	Verification of early incidence of post-operative delirium	Duration of delirium (days) as assessed by the number of positive CAM Scores as assessed by nursing/physicians (by chart review).	Day of surgery until five days post-operatively
Secondary	Late incidence of post-operative delirium	Duration of delirium (days) as assessed by the number of positive CAM scores as assessed by study investigator from post-operative day 6 to post-operative day 14 or discharge from hospital	Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.
Secondary	Verification of late incidence of post-operative delirium	Duration of delirium (days) as assessed by the number of positive CAM scores as assessed by nursing/physicians (by chart review) from post-operative day 6 to discharge from hospital	Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.
Secondary	Use of haloperidol post-operatively	Incidence (%) and total dose of haloperidol, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital	Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Secondary	Use of quetiapine post-operatively	Incidence (%) and total dose of quetiapine, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital.	Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Secondary	Use of risperidone post-operatively	Incidence (%) and total dose of risperidone, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital.	Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Secondary	Use of dexmedetomidine post-operatively	Incidence (%) of use of dexmedetomidine infusions, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from the intensive care unit.	Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..