Remifentanil and Glycemic Response in Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | January 2016 |
| End Date: | December 2017 |
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
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
