Phase 4
Completed N=116
Remifentanil and Glycemic Response in Cardiac Surgery
Source: ClinicalTrials.gov NCT02349152 ↗Enrolled (actual)
116
Serious AEs
5.7%
Results posted
May 2018
Primary outcomePrimary: Blood Glucose Values (More Than One ) > 180 mg% — 17; 33 Participants — p=0.001
◆ Published Evidence
Emerging
19citations · ~3 / year
Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.
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.
Linked Publications
-
Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Glucose Values (More Than One ) > 180 mg% |
17; 33 | 0.001 sig |
| SECONDARY Insulin Requirement |
2.9; 8.1 | 0.004 sig |
| SECONDARY Number of Blood Glucose Values > 180 mg% |
1.2; 2 | 0.01 sig |
| SECONDARY Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl) |
141; 156; 178; 205; 117; 120 | 0.0001 sig |
| SECONDARY Postoperative Blood Glucose |
139; 139; 185; 175 | 0.14 |
| SECONDARY Total Postoperative Regular Insulin |
28.1; 23.5 | 0.49 |
| SECONDARY Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability |
— | — |
| SECONDARY Stress Hormone Levels-Cortisol (µg/dl) |
12; 12; 6.0; 24.5; 5.0; 29.0 | 0.401 |
| SECONDARY Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml) |
1.2; 1.2; 1.1; 1.1; 1.2; 1.2 | 0.580 |
| SECONDARY Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml) |
7.4; 7.4; 4.4; 57.8; 4.4; 30.7 | 0.740 |
| SECONDARY Society of Thoracic Surgery Patient Outcomes |
1; 6; 3; 10; 0; 2 | 0.06 |
| SECONDARY Postoperative Pain |
6.63; 7.18; 6.53; 6.09; 6.59; 5.18 | 0.205 |
| SECONDARY Emergence From Anesthesia |
3; 2.5 | — |
| SECONDARY Wound Hyperalgesia |
3.24; 3.30; 3.71; 3.83; 3.60; 3.72 | — |
| SECONDARY Development of Chronic Pain |
1; 3; 0; 0; 0; 0 | — |
| SECONDARY Glycemic Variability |
0.2; 0.2 | 0.350 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02349152) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.