High spinal anesthesia for Delirium

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Boniface Hospital, Winnipeg, Canada
Delirium+2 More
Intrathecal bupivacaine and morphine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if high spinal anesthesia can help reduce post-operative delirium in cardiac surgery patients. High spinal anesthesia is used to treat delirium, and all patients in this trial will receive the treatment, rather than a placebo.

Eligible Conditions

  • Delirium
  • Post-Operative Confusion

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Delirium

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: One year

Hour 24
Vasopressor (norepinephrine, phenylephrine or vasopressin) use at 24 hours
30 days post surgery
Post-operative quality of recovery - one month
90 days post surgery
Post-operative quality of recovery - three months
Day of surgery
Incidence of intraoperative extubation
Intraoperative depth of anesthesia
Intraoperative end-tidal gas concentration
Intraoperative glucose level
Intraoperative hydromorphone administered
Intraoperative hypotension
Intraoperative insulin administered
Intraoperative ketamine administered
Intraoperative midazolam administered
Intraoperative sufentanil administered
Protocol adherence measure - establishment of spinal anesthetic
Day 14
Incidence of re-intubation
Day 14
Post-operative creatinine level
Day of surgery until five days post-operatively
Early incidence of post-operative delirium
Protocol adherence measure - completion of delirium assessments
Verification of early incidence of post-operative delirium
Day 14
Duration of ICU intubation
Major medical complications
Use of haloperidol post-operatively
Use of quetiapine post-operatively
Use of risperidone post-operatively
Day 3
Post-operative codeine administered
Post-operative fentanyl administered
Post-operative hydromorphone administered
Post-operative morphine administered
Return to OR for bleeding
Total RBC utilization
Total platelet utilization
Day 5
Use of dexmedetomidine post-operatively
First 12 hours postoperatively
Vasopressor (norepinephrine or phenylephrine or vasopressin) use at 12 hours
One year
Recruitment rate
Day 3
Post-operative pain scores at rest
Post-operative pain scores with deep breathing
Day 7
Vasopressor (norepinephrine, phenylephrine or vasopressin) use at >24 hours
Day 14
ICU re-admission
Day 14
Late incidence of post-operative delirium
Day 14
Verification of late incidence of post-operative delirium
Day 1
ICU length of stay
Time (days) in hospital from post-operative 1 to 30 (or through discharge from hospital)
Hospital length of stay

Trial Safety

Safety Progress

1 of 3

Other trials for Delirium

Trial Design

2 Treatment Groups

Control group
1 of 2
High spinal anesthesia
1 of 2
Active Control

50 Total Participants · 2 Treatment Groups

Primary Treatment: High spinal anesthesia · No Placebo Group · N/A

Control groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:
High spinal anesthesia
Drug
ActiveComparator Group · 1 Intervention: Intrathecal bupivacaine and morphine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
Closest Location: St. Boniface Hospital · Winnipeg, Canada
Photo of manitoba 1Photo of manitoba 2Photo of manitoba 3
2008First Recorded Clinical Trial
2 TrialsResearching Delirium
49 CompletedClinical Trials

Who is running the clinical trial?

University of ManitobaLead Sponsor
533 Previous Clinical Trials
186,077 Total Patients Enrolled
8 Trials studying Delirium
3,294 Patients Enrolled for Delirium
Doug Maguire, MDStudy DirectorUniversity of Manitoba

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.