Remifentanil and Glycemic Response in Cardiac Surgery

Condition(s) targeted: Heart Diseases; Hyperglycemia

Intervention: Remifentanil (Drug); Fentanyl (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Kathrivel Subramaniam, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Amy L Monroe, BS, Phone: 412-609-6161, Email: monroeal@upmc.edu

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.

Official title: The Effect of Intraoperative Continuous Remifentanil Infusion on Glycemic Response and Variability in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective, Randomized, Open Label Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Blood Glucose Levels

Glycemic variability

Insulin requirement

Secondary outcome:

Intraoperative Pre-cardiopulmonary bypass hemodynamic stability

Emergence from anesthesia

Stress hormone and inflammatory mediator levels

Postoperative pain

Wound hyperalgesia

Development of chronic pain

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Amy L Monroe, BS, Phone: 412-609-6161, Email: monroeal@upmc.edu

UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania 15213, United States; Not yet recruiting
Amy L Monroe, BS, Phone: 412-609-6161, Email: monroeal@upmc.edu
Kathirvel Subramaniam, MD, Principal Investigator
Stephen A Esper, MD, MBA, Sub-Investigator
Lawrence Wei, MD, Sub-Investigator
Jose Marquez, MD, Sub-Investigator
Arthur J Boujoukos, MD, Sub-Investigator
Vinay Badhwar, MD, Sub-Investigator
Frederico Toledo, MD, Sub-Investigator
Jodie Reider, MD, Sub-Investigator
Michael Pinsky, MD, Sub-Investigator
Andrew Murray, MD, Sub-Investigator

Starting date: February 2015
Last updated: January 27, 2015