Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of post operative pulmonary complications.
研究概览
简要总结
The purpose of this study is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).
详细描述
This is a local, multi-centre, prospective, randomised, double blinded trial of 976 patients.
Objectives:
The primary objective is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs). Secondary objectives are to determine if the use of sugammadex compared with traditional reversal agents improves patient quality of recovery, reduces the rate of postoperative nausea and vomiting and reduces the rate of airway complications in the Post Anaesthesia Care Unit (PACU).
Study procedures:
Following informed consent prior to surgery, patients will be randomised to two groups allocating drugs used for reversal of muscle relaxation;
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •patients presenting for non-cardiac surgery
- •planned operative time of over 1 hour
- •plan to be intubated and to receive muscle relaxants for their surgery
- •plan to stay at least one night in hospital
排除标准
- •Previous recruitment to the trial
- •Hypersensitivity to any of the study drugs
- •Patient refusal
- •Cognitive Impairment, or language proficiency leading to inability to complete QoR-15 questionnaire
- •Body Mass Index (BMI) >40
- •Planned postoperative intubation and ventilation
- •Liver failure with Child-Pugh class B/C
- •Renal failure with either regular peritoneal or haemodialysis or serum creatinine >140mcgmol/L
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study
研究组 & 干预措施
Sugammadex group
Sugammadex 2mg/kg intravenously at completion of surgery.
干预措施: Sugammadex (Drug)
Neostigmine/Glycopyrrolate group
Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.
干预措施: Neostigmine/Glycopyrrolate (Drug)
结局指标
主要结局
Incidence of post operative pulmonary complications.
时间窗: Up to day 2 post operatively.
Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.
次要结局
- Quality of Recovery Score (QoR-15)(Day 1 and Day 30 post operatively)
- Incidence of airway events in the Post Anaesthesia Care Unit (PACU).(Day of surgery.)
- Mortality(30 day)
- Incidence of post operative nausea and vomiting.(Day of surgery.)
- Hospital stay(30 days)