Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery

NCT01477151 | Completed Phase 4 DMC

• 1 other identifier: 16497
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based, but there remain significant gaps in our knowledge, even for commonly-encountered clinical situations. Currently, the two most commonly used drugs used for maintenance of anesthesia in cardiac surgical patients are isoflurane and sevoflurane. There is a belief among many cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane, but there is very little data to support this notion. In fact, very little is known about their comparative effects on important patient outcomes because there has not been a large head-to-head prospective randomized clinical trial. This project will supply the data necessary to critically compare the two anesthetics.

Conditions

Coronary Artery Disease; Valvular Heart Disease

Keywords

isoflurane; sevoflurane; troponin; anesthesia; cardioprotection; preconditioning; cardiac surgery; cardiac anesthesia

Outcome Measures

Primary Outcomes (1)

• Composite of: prolonged ICU stay (>= 48 hours) OR death within 30 days of operation

  30 days of operation

Secondary Outcomes (15)

• Postoperative cardiac troponin T

  6 hours after admission to ICU

• Length of stay in the ICU (criteria)

  Participants will be followed for the duration of ICU stay, an expected average of 1 day

• 30-day all-cause mortality

  30 days after operation

• Duration of tracheal intubation

  Participants will be followed for the duration of ICU stay, an expected average of 1 day

• Inotrope or vasopressor usage in the ICU

  Participants will be followed for the duration of ICU stay, an expected average of 1 day

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

These patients will receive sevoflurane as the volatile anesthetic pre-, during-, and post-cardiopulmonary bypass at a targeted dose of 0.5-2.0 MAC.

Drug: Volatile anesthetic

isoflurane

EXPERIMENTAL

These patients will receive isoflurane as the volatile anesthetic pre-, during-, and post-cardiopulmonary bypass at a targeted dose of 0.5-2.0 MAC.

Drug: Volatile anesthetic

Interventions

Volatile anesthetic DRUG

The intervention in this trial is randomization to either maintenance of anesthesia with sevoflurane or maintenance of anesthesia with isoflurane. The designated volatile anesthetic will be given at a strict minimal amount throughout the entire cardiac surgery (including cardiopulmonary bypass). This regimen (administration throughout the entire operation) has proved to have the greatest efficacy. Apart from this intervention, the anesthetic for patients participating in this trial will not be substantially different from normal practice, as the intention is to allow normal practice (with the exception of the choice of volatile anesthetic agent) to maximize the applicability and external validity of the trial. The management of anticoagulation, cardiac surgical techniques, and other aspects of the procedure will be managed in an unaltered fashion. No IV drug infusions will be permitted until after protamine administration.

isoflurane; sevoflurane

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 years or over (There is no upper age limit to enrollment)
• Eligible procedures are: CABG on-pump or off-pump, single valve repair/replacement, or CABG/single valve combined procedures

You may not qualify if:

• Cardiac surgeries that are not one of the included cases
• Planned extubation in the operating room
• Patients refusing blood products (vis à vis blood sampling)
• Pregnant patients
• Malignant hyperthermia or documented/stated allergy to potent volatile anesthetic agents

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

University Hospital - London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

• Jones PM, Bainbridge D, Chu MWA, Fernandes PS, Fox SA, Iglesias I, Kiaii B, Lavi R, Murkin JM. Comparison of isoflurane and sevoflurane in cardiac surgery: a randomized non-inferiority comparative effectiveness trial. Can J Anaesth. 2016 Oct;63(10):1128-1139. doi: 10.1007/s12630-016-0706-y. Epub 2016 Jul 27.

  PMID: 27465213 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Philip M Jones, MD MSc

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

CA (1)