Clinical trial NCT01477151: Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery
Official title: Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery: A Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Valvular Heart Disease
Keywords: isoflurane
sevoflurane
troponin
anesthesia
cardioprotection
preconditioning
cardiac surgery
cardiac anesthesia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Current evidence supports the superiority of sevoflurane for myocardial protection during cardiac surgery when compared to total intravenous anesthesia with propofol. However, there is no evidence to suggest that sevoflurane is superior to isoflurane for myocardial protection during cardiac surgery. Sevoflurane may potentially reduce the rate of post-cardiac surgery atrial fibrillation and the time to tracheal extubation compared to isoflurane, but the literature is equivocal on these two important outcomes. Anesthesiologists still frequently use isoflurane for maintenance of cardiac anesthesia, and this is likely because there is substantial uncertainty about whether or not sevoflurane is superior to isoflurane, given the lack of head-to-head RCTs. A large, prospective, pragmatic RCT can ultimately assist clinicians by providing evidence of the non-inferiority (or, possibly the superiority) of one anesthetic compared to the other on important patient outcomes such as ICU length of stay, mortality, renal dysfunction, time to tracheal extubation after cardiac surgery, rates of clinically-important atrial fibrillation, and myocardial damage.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Composite of: prolonged ICU stay (>= 48 hours) OR death within 30 days of operation
timeFrame: 30 days of operation
Secondary outcomes:
measure: Postoperative cardiac troponin T
timeFrame: 6 hours after admission to ICU
measure: Length of stay in the ICU (criteria)
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: 30-day all-cause mortality
timeFrame: 30 days after operation
measure: Duration of tracheal intubation
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: Inotrope or vasopressor usage in the ICU
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: Prolonged inotrope or vasopressor usage in the ICU
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: Peak postoperative serum creatinine
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: New-onset dialysis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Incidence of new-onset atrial fibrillation
timeFrame: Until end of post-operative day 4
measure: Incidence of intra-aortic balloon pump usage
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: Length of stay in the ICU (actual)
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 1 day
measure: Length of stay in the hospital (actual)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Readmission to ICU
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Perioperative stroke
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: 1-year all-cause mortality
timeFrame: One year after operation
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Philip M Jones, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.