Remifentanil and Glycemic Response in Cardiac Surgery

Kathirvel Subramaniam

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Heart Diseases

Treatments: Drug: Fentanyl; Drug: Remifentanil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02349152

PRO14110258

Details and patient eligibility

About

This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.

Full description

Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.

Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.

NOTE;

Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.

Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries)
• Surgery with use of cardiopulmonary bypass
• Patients over 18 years of age
• Both female and male genders
• All races

Exclusion criteria

• Minimally invasive heart surgery through thoracotomy approach
• Patients receiving regional analgesia such as intrathecal morphine
• Patients undergoing procedures under deep hypothermic circulatory arrest
• Patients with active infections such as acute infective endocarditis
• Emergency surgery
• Patients undergoing transplantations and ventricular assist device insertion
• Patients on any mechanical circulatory support preoperatively
• Patient's refusal
• Allergy to remifentanil
• Positive pregnancy test
• Morbid obesity
• End stage liver and kidney disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Remifentanil group

Experimental group

Description:

Half of subjects enrolled will be randomized to the remifentanil group

Treatment:

Drug: Remifentanil

Fentanyl group

Active Comparator group

Description:

Half of subjects enrolled will be randomized to the fentanyl group

Treatment:

Drug: Fentanyl