UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT02349152
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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)
Time frame: Intraoperative period; Induction to end of surgery
Average dose of insulin (Units/ml) calculated for each group in the intraoperative period
Time frame: Intraoperative period, Induction to end of surgery
Blood glucose values that exceed 180 mg% will be counted
Time frame: Intraoperative period; Induction to end of surgery
Blood glucose measured every hour
Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively
Mean and peak blood glucose levels postoperatively
Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively
Total units of regular insulin required post-operatively
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
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
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
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
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)
Time frame: Every day 6 hour for 48 hours postoperative period
Pain scores; Every day 6 hour for 48 hours postoperative period
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
Time frame: 96 hours postoperatively
Von frey hair objective testing
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.
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.
Kathirvel Subramaniam
Other
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
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