High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

Study Overview
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Brief Summary
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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
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Intervention Patients will be randomized to either general anesthesia (GA) or HSA + GA. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). 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. 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. 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. The routine postoperative care map for the postoperative cardiac intensive care unit (ICCS) will be followed. 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. 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.

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

Conditions
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Post-Operative Confusion

Intervention / Treatment
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* Drug: Intrathecal bupivacaine and morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to either general anesthesia (GA) or HSA + GA.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High spinal anesthesia<br>Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). 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. 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. | Drug: Intrathecal bupivacaine and morphine<br>* Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).<br>* Other names: Drug: preservative free morphine 3 mcg/kg;|
| No Intervention: Control group<br>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. 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Mean number of patients recruited per week) (n) | 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. | 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. | Day of surgery until five days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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.. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Delirium, Spinal anesthesia