High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery
- Conditions
- Post-Operative Confusion
- Interventions
- Drug: Intrathecal bupivacaine and morphine
- Registration Number
- NCT05374356
- Lead Sponsor
- University of Manitoba
- Brief 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Adult (>18 years old) patients
- Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High spinal anesthesia Intrathecal bupivacaine and morphine 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.
- Primary Outcome Measures
Name Time Method Protocol adherence measure - establishment of spinal anesthetic Day of surgery 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.
Protocol adherence measure - completion of delirium assessments Day of surgery until five days post-operatively In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence.
Recruitment rate One year Mean number of patients recruited per week) (n)
- Secondary Outcome Measures
Name Time Method Early incidence of post-operative delirium Day of surgery until five days post-operatively Duration of delirium (days) as assessed by the number of positive Confusion Assessment Method (CAM) as assessed by study investigator
Verification of early incidence of post-operative delirium Day of surgery until five days post-operatively Duration of delirium (days) as assessed by the number of positive CAM Scores as assessed by nursing/physicians (by chart review).
Late incidence of post-operative delirium Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first. 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
Use of risperidone post-operatively Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. 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.
Use of dexmedetomidine post-operatively Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first.. 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.
Use of haloperidol post-operatively Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. 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
Use of quetiapine post-operatively Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. 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.
Verification of late incidence of post-operative delirium Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first. 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
Trial Locations
- Locations (1)
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada