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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

Study Summary

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

Eligible Conditions

Postoperative 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protocol adherence measure - completion of delirium assessments

Protocol adherence measure - establishment of spinal anesthetic

Recruitment rate

Secondary outcome measures

Early incidence of post-operative delirium

Late incidence of post-operative delirium

Use of dexmedetomidine post-operatively

+5 more

Other outcome measures

Duration of ICU intubation

Hospital length of stay

ICU length of stay

+28 more

Trial Design

2Treatment groups

Active Control

Group I: High spinal anesthesiaActive Control1 Intervention

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.

Group II: Control groupActive Control1 Intervention

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.

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Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,472 Total Patients Enrolled

8 Trials studying Delirium

3,319 Patients Enrolled for Delirium

Doug Maguire, MDStudy DirectorUniversity of Manitoba

Media Library

Delirium Research Study Groups: High spinal anesthesia, Control group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can potentially participate in this experiment?

"Affirmative. The clinicaltrials.gov database specifies that this experiment is currently recruiting participants, and the protocol was initially published on May 1st 2022 with its most recent modification occurring on May 9th 2022. This initiative requires 50 volunteers from a single site."

Answered by AI

Are there any vacancies for individuals to partake in this clinical trial?

"According to clinicaltrials.gov, this medical experiment is still in search of volunteers. It was first made visible on May 1st 2022 and most recently updated on the 9th of that same month."

Answered by AI

What end-result is this clinical trial aiming to achieve?

"This trial's primary outcome, that will be tracked over a 12 month period, is to assess patient adherence as measured by delirium evaluations. Secondary outcomes include an early estimation of post-operative delirium (based off Confusion Assessment Method results), the use of risperidone for agitation management and haloperidol dosage for agitation relief from day one until hospital discharge."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

2022. "High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374356.

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