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Spinal Anesthesia for Delirium

N/A

Waitlist Available

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if high spinal anesthesia can help reduce post-operative delirium in cardiac surgery patients.

Eligible Conditions

Delirium

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Protocol adherence measure - completion of delirium assessments

Protocol adherence measure - establishment of spinal anesthetic

Recruitment rate

Secondary study objectives

Early incidence of post-operative delirium

Late incidence of post-operative delirium

Use of dexmedetomidine post-operatively

+5 more

Other study objectives

Duration of ICU intubation

Hospital length of stay

ICU length of stay

+28 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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