High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

NCT05374356 | Unknown

• 1 other identifier: HS23755 B2020:026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Confusion

Keywords

Cardiac surgery; Delirium; Spinal anesthesia

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Mean number of patients recruited per week) (n)

  One year

• Protocol adherence measure - establishment of spinal anesthetic

  In order to assess protocol adherence (%), in patients randomized to spinal anesthesia, an 80% success rate in establishing a spinal anesthetic will be considered as protocol adherence.

  Day of surgery

• Protocol adherence measure - completion of delirium assessments

  In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence.

  Day of surgery until five days post-operatively

Secondary Outcomes (8)

• Early incidence of post-operative delirium

  Day of surgery until five days post-operatively

• Verification of early incidence of post-operative delirium

  Day of surgery until five days post-operatively

• Late incidence of post-operative delirium

  Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.

• Verification of late incidence of post-operative delirium

  Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.

• Use of haloperidol post-operatively

  Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.

Other Outcomes (31)

• Incidence of intraoperative extubation

  Day of surgery

• Duration of ICU intubation

  Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.

• Post-operative pain scores at rest

  Post-operative day 1 until post-operative day 3

Study Arms (2)

High spinal anesthesia

ACTIVE COMPARATOR

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.

Drug: Intrathecal bupivacaine and morphine

Control group

NO 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.

Interventions

Intrathecal bupivacaine and morphine DRUG

Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).

Also known as: Drug: bupivacaine 0.75% in dextrose (0.3 to 0.6 mls/kg), Drug: preservative free morphine 3 mcg/kg

High spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years old) patients
• Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Delirium

Interventions

Morphine; Bupivacaine; Glucose

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Doug Maguire, MD

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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. The data collectors will not be aware whether the patient had a spinal anesthetic or not.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either general anesthesia (GA) or HSA + GA.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 16, 2022
• Study Start: May 2, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 28, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)