Remifentanil and Glycemic Response in Cardiac Surgery

NCT02349152 | Completed Phase 4 Results DMC

• 1 other identifier: PRO14110258
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Diseases; Hyperglycemia

Keywords

Cardiopulmonary bypass; Heart surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Insulin Requirement

  Intraoperative period; Induction to end of surgery

• Number of Blood Glucose Values > 180 mg%

  Intraoperative period, Induction to end of surgery

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

  Intraoperative period; Induction to end of surgery

• Postoperative Blood Glucose

  From ICU Admission (After Surgery) Until 24 hours postoperatively

• Total Postoperative Regular Insulin

  From ICU Admission (After Surgery) Until 24 hours postoperatively

Study Arms (2)

Remifentanil group

EXPERIMENTAL

Half of subjects enrolled will be randomized to the remifentanil group

Drug: Remifentanil

Fentanyl group

ACTIVE COMPARATOR

Half of subjects enrolled will be randomized to the fentanyl group

Drug: Fentanyl

Interventions

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.

Also known as: Ultiva

Remifentanil group

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.

Fentanyl group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathirvel Subramaniam: lead
• Mylan Inc.: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• 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. doi: 10.1016/j.jtcvs.2005.05.049.

  PMID: 16214532 BACKGROUND

• 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. doi: 10.1177/147323000903700612.

  PMID: 20146874 BACKGROUND

• 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):277-287. doi: 10.1213/ANE.0000000000000100.

  PMID: 24445629 BACKGROUND

• 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.

  PMID: 23837943 BACKGROUND

• 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.

  PMID: 21602751 BACKGROUND

• 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. No abstract available.

  PMID: 19161815 BACKGROUND

• Subramaniam K, Sciortino C, Ruppert K, Monroe A, Esper S, Boisen M, Marquez J, Hayanga H, Badhwar V. Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial. Br J Anaesth. 2020 Jun;124(6):684-692. doi: 10.1016/j.bja.2020.01.028. Epub 2020 Apr 2.

  PMID: 32247539 DERIVED

MeSH Terms

Conditions

Heart Diseases; Hyperglycemia

Interventions

Remifentanil; Fentanyl

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Kathirvel Subramaniam, MD, MPH
• Organization: University of Pittsburgh

subramaniamk@upmc.edu

412-647-5635

Study Officials

• Kathrivel Subramaniam, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Visiting Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 21, 2020
• Results First Posted: May 14, 2018

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)