Heart Diseases Clinical Trial
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
Verified date | April 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kathirvel Subramaniam | Mylan Inc. |
United States,
Cok OY, Ozkose Z, Pasaoglu H, Yardim S. Glucose response during craniotomy: propofol-remifentanil versus isoflurane-remifentanil. Minerva Anestesiol. 2011 Dec;77(12):1141-8. Epub 2011 May 20. — View Citation
Doenst T, Wijeysundera D, Karkouti K, Zechner C, Maganti M, Rao V, Borger MA. Hyperglycemia during cardiopulmonary bypass is an independent risk factor for mortality in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2005 Oct;130(4):1144. — View Citation
Ihn CH, Joo JD, Choi JW, Kim DW, Jeon YS, Kim YS, Jung HS, Kwon SY. Comparison of stress hormone response, interleukin-6 and anaesthetic characteristics of two anaesthetic techniques: volatile induction and maintenance of anaesthesia using sevoflurane versus total intravenous anaesthesia using propofol and remifentanil. J Int Med Res. 2009 Nov-Dec;37(6):1760-71. — View Citation
Lazar HL, McDonnell M, Chipkin SR, Furnary AP, Engelman RM, Sadhu AR, Bridges CR, Haan CK, Svedjeholm R, Taegtmeyer H, Shemin RJ; Society of Thoracic Surgeons Blood Glucose Guideline Task Force. The Society of Thoracic Surgeons practice guideline series: Blood glucose management during adult cardiac surgery. Ann Thorac Surg. 2009 Feb;87(2):663-9. doi: 10.1016/j.athoracsur.2008.11.011. Review. — View Citation
Shinoda T, Murakami W, Takamichi Y, Iizuka H, Tanaka M, Kuwasako Y. Effect of remifentanil infusion rate on stress response in orthopedic surgery using a tourniquet application. BMC Anesthesiol. 2013 Jul 10;13:14. doi: 10.1186/1471-2253-13-14. eCollection 2013. — View Citation
Subramaniam B, Lerner A, Novack V, Khabbaz K, Paryente-Wiesmann M, Hess P, Talmor D. Increased glycemic variability in patients with elevated preoperative HbA1C predicts adverse outcomes following coronary artery bypass grafting surgery. Anesth Analg. 2014 Feb;118(2):277-87. doi: 10.1213/ANE.0000000000000100. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
Intraoperative period | |
Secondary | Insulin Requirement | Average dose of insulin (Units/ml) calculated for each group in the intraoperative period | Intraoperative period; Induction to end of surgery | |
Secondary | Number of Blood Glucose Values > 180 mg% | Blood glucose values that exceed 180 mg% will be counted | Intraoperative period, Induction to end of surgery | |
Secondary | Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl) | Blood glucose measured every hour | Intraoperative period; Induction to end of surgery | |
Secondary | Postoperative Blood Glucose | Mean and peak blood glucose levels postoperatively | From ICU Admission (After Surgery) Until 24 hours postoperatively | |
Secondary | Total Postoperative Regular Insulin | Total units of regular insulin required post-operatively | From ICU Admission (After Surgery) Until 24 hours postoperatively | |
Secondary | 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 | induction of anesthesia till systemic heparinization before cardiopulmonary bypass | |
Secondary | Stress Hormone Levels-Cortisol (µg/dl) | 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 | Perioperative period (Intraoperatively and 8 hours postoperatively) | |
Secondary | Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml) | 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 | Perioperative period (Intraoperatively and 8 hours postoperatively) | |
Secondary | Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml) | 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 | Perioperative period (Intraoperatively and 8 hours postoperatively) | |
Secondary | Society of Thoracic Surgery Patient 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) | 30 day outcomes | |
Secondary | Postoperative Pain | Pain scores; Every day 6 hour for 48 hours postoperative period | Every day 6 hour for 48 hours postoperative period | |
Secondary | Emergence From Anesthesia | Time to extubation after completion of surgery in the operating room and intensive care unit | Immediate postoperative period until 30 days post-operatively | |
Secondary | Wound Hyperalgesia | Von frey hair objective testing | 96 hours postoperatively | |
Secondary | Development of Chronic Pain | Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain. | 1, 3, 6 and 12 months after discharge from the hospital | |
Secondary | Glycemic Variability | Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation. | From the start of induction till 24 hours postoperatively |
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