Clinical trial NCT05374356: High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery
Official title: High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Operative Confusion
Keywords: Cardiac surgery
Delirium
Spinal anesthesia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either general anesthesia (GA) or HSA + GA.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: One year
measure: Protocol adherence measure - establishment of spinal anesthetic
timeFrame: Day of surgery
measure: Protocol adherence measure - completion of delirium assessments
timeFrame: Day of surgery until five days post-operatively
Secondary outcomes:
measure: Early incidence of post-operative delirium
timeFrame: Day of surgery until five days post-operatively
measure: Verification of early incidence of post-operative delirium
timeFrame: Day of surgery until five days post-operatively
measure: Late incidence of post-operative delirium
timeFrame: Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.
measure: Verification of late incidence of post-operative delirium
timeFrame: Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Use of haloperidol post-operatively
timeFrame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Use of quetiapine post-operatively
timeFrame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Use of risperidone post-operatively
timeFrame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Use of dexmedetomidine post-operatively
timeFrame: Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..
Other outcomes:
measure: Incidence of intraoperative extubation
timeFrame: Day of surgery
measure: Duration of ICU intubation
timeFrame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Post-operative pain scores at rest
timeFrame: Post-operative day 1 until post-operative day 3
measure: Post-operative pain scores with deep breathing
timeFrame: Post-operative day 1 until post-operative day 3
measure: Post-operative hydromorphone administered
timeFrame: Day of surgery until post-operative day 3
measure: Post-operative fentanyl administered
timeFrame: Day of surgery until post-operative day 3
measure: Post-operative codeine administered
timeFrame: Day of surgery until post-operative day 3
measure: Post-operative morphine administered
timeFrame: Day of surgery until post-operative day 3
measure: Intraoperative hypotension
timeFrame: Day of surgery
measure: Intraoperative end-tidal gas concentration
timeFrame: Day of surgery
measure: Intraoperative depth of anesthesia
timeFrame: Day of surgery
measure: Intraoperative sufentanil administered
timeFrame: Day of surgery
measure: Intraoperative hydromorphone administered
timeFrame: Day of surgery
measure: Intraoperative midazolam administered
timeFrame: Day of surgery
measure: Intraoperative ketamine administered
timeFrame: Day of surgery
measure: Intraoperative glucose level
timeFrame: Day of surgery
measure: Intraoperative insulin administered
timeFrame: Day of surgery
measure: Total RBC utilization
timeFrame: Day of surgery until post-operative day 3
measure: Total platelet utilization
timeFrame: Day of surgery until post-operative day 3
measure: Return to OR for bleeding
timeFrame: Day of surgery until post-operative day 3
measure: Vasopressor (norepinephrine or phenylephrine or vasopressin) use at 12 hours
timeFrame: First 12 hours postoperatively
measure: Vasopressor (norepinephrine, phenylephrine or vasopressin) use at 24 hours
timeFrame: 12 to 24 hours postoperatively
measure: Vasopressor (norepinephrine, phenylephrine or vasopressin) use at >24 hours
timeFrame: Post-operative day 2 to post-operative day 7
measure: Incidence of re-intubation
timeFrame: Day of surgery until 14 days post-operatively or discharge from hospital, whichever occurs first.
measure: ICU re-admission
timeFrame: Post-operative day 2 until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Hospital length of stay
timeFrame: Time (days) in hospital from post-operative 1 to 30 (or through discharge from hospital)
measure: ICU length of stay
timeFrame: Time (days) in ICU from post-operative day 1 to 5 (or through discharge from hospital)
measure: Major medical complications
timeFrame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
measure: Post-operative quality of recovery - one month
timeFrame: 30 days post surgery
measure: Post-operative quality of recovery - three months
timeFrame: 90 days post surgery
measure: Post-operative creatinine level
timeFrame: Day of surgery until 14 days post-operatively or hospital discharge, whichever occurs first.
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Doug Maguire, MD
role: STUDY_DIRECTOR
References: