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NCT Number: NCT02349152

Remifentanil and Glycemic Response in Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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.

Other names: Ultiva

Fentanyl

Drug

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.

Primary outcomes

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

    Time frame: Intraoperative period

    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)

Secondary outcomes

  1. Insulin Requirement

    Time frame: Intraoperative period; Induction to end of surgery

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

  2. Number of Blood Glucose Values > 180 mg%

    Time frame: Intraoperative period, Induction to end of surgery

    Blood glucose values that exceed 180 mg% will be counted

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

    Time frame: Intraoperative period; Induction to end of surgery

    Blood glucose measured every hour

  4. Postoperative Blood Glucose

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

    Mean and peak blood glucose levels postoperatively

  5. Total Postoperative Regular Insulin

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

    Total units of regular insulin required post-operatively

  6. Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability

    Time frame: induction of anesthesia till systemic heparinization before cardiopulmonary bypass

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

  7. Stress Hormone Levels-Cortisol (µg/dl)

    Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)

    Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period

  8. Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)

    Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)

    Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period

  9. Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)

    Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)

    Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period

  10. Society of Thoracic Surgery Patient Outcomes

    Time frame: 30 day outcomes

    Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7)

  11. Postoperative Pain

    Time frame: Every day 6 hour for 48 hours postoperative period

    Pain scores; Every day 6 hour for 48 hours postoperative period

  12. Emergence From Anesthesia

    Time frame: Immediate postoperative period until 30 days post-operatively

    Time to extubation after completion of surgery in the operating room and intensive care unit

  13. Wound Hyperalgesia

    Time frame: 96 hours postoperatively

    Von frey hair objective testing

  14. Development of Chronic Pain

    Time frame: 1, 3, 6 and 12 months after discharge from the hospital

    Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain.

  15. Glycemic Variability

    Time frame: From the start of induction till 24 hours postoperatively

    Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation.

Sponsors and collaborators

Lead sponsor

Kathirvel Subramaniam

Other

Collaborators

  • Mylan Inc.

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 28, 2015
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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