Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Plasmatic Glucose Levels (mg/dl).
研究概览
简要总结
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
详细描述
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patient (BMI>30)
- •American Society of Anesthesiologists grades II or III
- •Diagnosis of impaired glucose tolerance
- •Undergoing sleeve gastrectomy
排除标准
- •Baseline glucose > 200mg/dl
- •Diagnosis of Diabetes
- •Under corticosteroids treatment
- •Oral hypoglycemic medication within 7 days previous surgery
- •Use of insulin within 24h previous surgery
- •Allergy to any drug used in the study
研究组 & 干预措施
Dexmedetomidine
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: Fentanyl (Drug)
Dexmedetomidine
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: Morphine Sulfate (Drug)
0.9% Sodium-chloride
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: 0.9% Sodium-chloride (Drug)
0.9% Sodium-chloride
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: Fentanyl (Drug)
0.9% Sodium-chloride
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Plasmatic Glucose Levels (mg/dl).
时间窗: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Change of baseline glucose levels within the first 12 postoperative hours.
Plasmatic Insulin Levels (uU/ml).
时间窗: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Change of baseline insulin levels within the first 12 postoperative hours.
次要结局
- Fentanyl Consumption.(Since the beginning of anesthesia until the end of it, an average of one hour and a half.)
- Amount (mg) of Morphine Consumed.(At 24h postoperative hours.)
- Pain Scores in the First 24 Postoperative Hours.(At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).)
- Sedation-agitation Scores in the First 12 Postoperative Hours.(At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).)
- Postoperative Nausea and Vomiting.(Postoperative nausea and vomiting during the first 12 postoperative hours.)
研究者
Eduardo Vega
Instructor
Pontificia Universidad Catolica de Chile