Spinal Anesthesia for Delirium

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Manitoba

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Doug Maguire, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

Inclusion Criteria

You are 18 years old or older.

You are planning to have heart surgery with a heart-lung machine, either as a scheduled procedure or in an emergency.

Exclusion Criteria

You have been diagnosed with conditions like schizophrenia or bipolar disorder before joining the study.

You have had a complicated surgery on your aorta, such as repair of the hemi-arch or surgery on the descending thoracic area.

You have a condition that makes it hard for doctors to put a breathing tube in while you are awake.

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Treatment Details

Interventions

Bupivacaine (Local Anesthetic)
Morphine (Opioid Analgesic)

Participant Groups

2Treatment groups

Active Control

Group I: High spinal anesthesiaActive Control1 Intervention

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.

Group II: Control groupActive Control1 Intervention

1. 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. 2. 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.