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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
50
Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Recruitment rate
Mean number of patients recruited per week) (n)
Time frame: One year
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.
Time frame: Day of surgery
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.
Time frame: Day of surgery until five days post-operatively
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
Time frame: Day of surgery until five days post-operatively
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).
Time frame: Day of surgery until five days post-operatively
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
Time frame: Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.
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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
Time frame: Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.
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
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
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.
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
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.
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
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.
Time frame: Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..