Remifentanil and Glycemic Response in Cardiac Surgery

Kathirvel Subramaniam116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

116

Conditions

Heart Diseases Hyperglycemia

Interventions

RemifentanilDRUG

Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.

FentanylDRUG

Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Blood Glucose Values (More Than One ) > 180 mg%

Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)

Time frame: Intraoperative period

Secondary Outcomes

Insulin Requirement

Average dose of insulin (Units/ml) calculated for each group in the intraoperative period

Time frame: Intraoperative period; Induction to end of surgery

Number of Blood Glucose Values > 180 mg%

Blood glucose values that exceed 180 mg% will be counted

Time frame: Intraoperative period, Induction to end of surgery

Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)

Blood glucose measured every hour

Time frame: Intraoperative period; Induction to end of surgery

Postoperative Blood Glucose

Mean and peak blood glucose levels postoperatively

Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively

Total Postoperative Regular Insulin

Total units of regular insulin required post-operatively

Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively

Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability

Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass

Data from ClinicalTrials.gov

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