Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 24 hours morphine consumption
研究概览
简要总结
This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery
详细描述
Patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. Allocation concealment is established on opaque envelopes that contain random allocation.
Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.
At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.
Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI <35
排除标准
- •Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers
研究组 & 干预措施
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: Atropine (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: Sevoflurane (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: sugammadex (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: Ketorolac (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: Morphine PCA (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: rocuronium (Drug)
Atropine
Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia
干预措施: propofol (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: Placebo (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: Sevoflurane (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: sugammadex (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: Ketorolac (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: Morphine PCA (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: rocuronium (Drug)
placebo
Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
干预措施: propofol (Drug)
结局指标
主要结局
24 hours morphine consumption
时间窗: 24 hours
morphine consumption, measured 24 post hours, in mg
次要结局
- number of patients that refer mouth dryness(24 hours)
- Pain Visual analog scale at 24 hours(24 hours)
- pain visual analog scale at postanesthesia care unit(2 hours post)
- Patient satisfaction, on a qualitative scale(up to three days)
- number of patients with postoperative nausea and/or vomiting(24 hours)
- number of patients that refer palpitations(24 hours)
- number of patients that refer blurred vision(24 hours)
研究者
David Torres
Principal Investigator
Clinica Santa Maria