NCT05031234已完成不适用
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年12月17日最近更新:
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
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Morphine Use
研究概览
简要总结
Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery
详细描述
Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.
- Group 1: conventional general anaesthesia with morphine
- Group 2: general anaesthesia without opiates
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
- Single (Participant)
盲法说明
The patient does not know which treatment is used for the anesthesia
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
- •Patient over 18 years of age who has read and signed the consent form for participation in the study
- •Patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy
排除标准
- •Severe renal failure with baseline clearance<30, hepatic failure with baseline PT<40%, cardiac failure with LVEF<20%.
- •Patient under court protection, guardianship or curatorship
- •Pregnant or breastfeeding patient
- •Patient not affiliated to the French social security system
- •Impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
- •Contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol
- •Patient participating in another interventional research or in a period of exclusion from a previous research
研究组 & 干预措施
Group with morphine
Active Comparator
conventional general anaesthesia with morphine
干预措施: anaesthesia with morphine (Drug)
Group without opiates
Experimental
general anaesthesia without opiates
干预措施: anaesthesia without opiates (Drug)
结局指标
主要结局
Morphine Use
时间窗: 48 hours
All intravenous and oral morphine consumed in the first 48 hours after surgery
次要结局
- Duration of Mean arterial pressure <65(48 hours)
- Postoperative pain H12(Hour 12)
- Duration of Mean arterial pressure <55(48 hours)
- Average heart rate(48 hours)
- Mean arterial pressure(48 hours)
- Mean arterial pressure variability(48 hours)
- Postoperative pain H24(Hour 24)
- Postoperative pain H36(Hour 36)
- Postoperative pain H48(Hour 48)
- Postoperative pain D30(Day 30)
- Atropine dose administered(48 hours)
- Heart rate variability(48 hours)
- Bradycardia duration < 50(48 hours)
- Ephedrine dose administered(48 hours)
- Noradrenaline dose administered(48 hours)
- Neosynephrine dose administered(48 hours)
- Urapidil dose(48 hours)
- Nicardipine dose(48 hours)
- Postoperative hypoxemia(48 hours)
- Consumption of non-morphine drug(Day 90)
- Assessment of tolerance(Day 90)
- Assessment of disability(Day 90)
- Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay(Day 90 at least)
- Immediate postoperative hypoxemia(Day 1)
- Oxygen requirement(Day 2)
研究者
研究点 (1)
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