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临床试验/NCT03378674
NCT03378674已完成不适用

Effect of Different Doses of Remifentanil on Stress Response During Laparoscopic Cholecystectomy

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Growth hormone levels changes

研究概览

简要总结

Perioperative adequate analgesia reduces neuroendocrine stress response and postoperative complications. Because opioids are the most effective parenteral drugs to control pain and stress response, in this prospective randomized double-blinded controlled study we supposed that higher dose of remifentanil may reduce stress marker variations compared to lower dose in patients undergoing laparoscopic cholecystectomy.

详细描述

Fifty Caucasian patients, aged 20-70 years, with American Society of Anesthesiologist physical status I-II, undergoing laparoscopic cholecystectomy were enrolled. Exclusion criteria were: patient refusal, thyroid disorders, diabetes mellitus, BMI > 30, use of corticosteroids, benzodiazepines or antipsychotics drugs. No patient received premedication. Before entering the operating room, venous access was established (18 G in the antecubital vein) where the first blood sample (Time 0) was collected to measure adrenocorticotropic hormone (ACTH), Cortisol, Growth hormone (GH) and prolactin (PRL) levels. Then a second venous access was established (18 G on the other arm) to start a fluid infusion (normal saline to replace half of the water deficit from preoperative fasting followed by a maintenance infusion of 2 ml/kg/h). Heart Rate (HR), Non Invasive Blood Pressure (NIBP), Bispectral Index (BIS), End-tidal CO2 (EtCO2) were recorded every 5 minutes. Patients were randomly assigned to receive two different dosages of remifentanil: 0,15 mcg/kg/min (group A) and 0,30 mcg/kg/min (group B) for the induction and the maintenance of anesthesia, using a computer generated randomization table (Table I). Anesthesia was induced with propofol 2 mg/kg, cisatracurium 0,15 mg/kg and remifentanil infusion of 0,15 mcg/Kg/min (Group A) or 0,3 mcg/Kg/min (Group B) was started. Anesthesia was maintained with desflurane at a variable concentration in order to maintain the BIS between 40 and 60. The second blood sample was collected at the trocar insertion (Time 1), and the third sample one hour after the end of the surgery (Time 2). Postoperative analgesia was standardized using intravenous acetaminophen 1 g and morphine 0,1 mg/kg 30 minutes before the end of the surgery. Rescue analgesia in Recovery Room was provided by intravenous tramadol 1 mg/Kg.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist physical status I-II
  • Undergoing laparoscopic cholecystectomy

排除标准

  • patient refusal,
  • thyroid disorders,
  • diabetes mellitus,
  • BMI > 30,
  • use of corticosteroids, benzodiazepines or antipsychotics drugs

研究组 & 干预措施

Group A

Experimental

remifentanil infusion of 0,15 mcg/Kg/min

干预措施: Remifentanil Injectable Product (Drug)

Group B

Active Comparator

remifentanil infusion of 0,3 mcg/Kg/min

干预措施: Remifentanil Injectable Product (Drug)

结局指标

主要结局

Growth hormone levels changes

时间窗: changes between basal, incision,one hour after surgery

prolactin levels changes

时间窗: changes between basal, incision,one hour after surgery

ACTH levels changes

时间窗: changes between basal, incision,one hour after surgery

Cortisol levels changes

时间窗: changes between basal, incision,one hour after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Germano De Cosmo

professor

Catholic University of the Sacred Heart

研究点 (1)

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