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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Blood Glucose Values (More Than One ) > 180 mg%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Remifentanil group
Half of subjects enrolled will be randomized to the remifentanil group
干预措施: Remifentanil (Drug)
Fentanyl group
Half of subjects enrolled will be randomized to the fentanyl group
干预措施: Fentanyl (Drug)
结局指标
主要结局
Blood Glucose Values (More Than One ) > 180 mg%
时间窗: 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)
次要结局
- Glycemic Variability(From the start of induction till 24 hours postoperatively)
- Emergence From Anesthesia(Immediate postoperative period until 30 days post-operatively)
- 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)
- Total Postoperative Regular Insulin(From ICU Admission (After Surgery) Until 24 hours postoperatively)
- Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability(induction of anesthesia till systemic heparinization before cardiopulmonary bypass)
- Wound Hyperalgesia(96 hours postoperatively)
- Development of Chronic Pain(1, 3, 6 and 12 months after discharge from the hospital)
- Stress Hormone Levels-Cortisol (µg/dl)(Perioperative period (Intraoperatively and 8 hours postoperatively))
- Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)(Perioperative period (Intraoperatively and 8 hours postoperatively))
- Society of Thoracic Surgery Patient Outcomes(30 day outcomes)
- Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)(Perioperative period (Intraoperatively and 8 hours postoperatively))
- Postoperative Pain(Every day 6 hour for 48 hours postoperative period)
- Insulin Requirement(Intraoperative period; Induction to end of surgery)
- Postoperative Blood Glucose(From ICU Admission (After Surgery) Until 24 hours postoperatively)
研究者
Kathirvel Subramaniam
Visiting Associate Professor in Anesthesiology
University of Pittsburgh