Phase 4 Study of Optimal Relaxation With Rocuronium Infusion Followed by Rapid Reliable Reversal With Sugammadex: A Comparison With Conventional Practice
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- speed of reversal
研究概览
简要总结
Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide better quality of muscle relaxation and rapid recovery from anaesthesia compared with intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.
50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90 minutes will be randomised into 2 treatment arms: CI-sugammadex & IB-Neostigmine.
After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be started on rocuronium infusion immediately and rate adjusted according to the targeted PTC of 1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at reappearance of TOFC of 2.
At the end of the surgery, the subject will be reversed with either sugammadex or neostigmine at different depth of block, ie PTC 1-2 and TOFC 2 respectively.
Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique, CI-Sugammadex and IB-Neostigmine will be compared with respect to:
- Time to full reversal (T4/T1 [TOF] ratios ≥ 0.9) of neuromuscular blockade from:
- PTC 1-2 in CI-Sugammadex group
- TOFC ≥2 in IB-Neostigmine group
- Incidence of residual neuromuscular blockade (T4/T1 ratios < 0.9)
- Improved quality of intraoperative neuromuscular relaxation by maintaining profound neuromuscular blockade, as reflected by reduced incidence of intraoperative events and high VAS grading of relaxation quality by surgeon
详细描述
Epidural will be established before induction of a standard balanced general anesthesia. After the epidural, they will be randomized into 2 groups, the CI-Sugammadex group and the IB-Neostigmine group.
Intra operative analgesia will be achieved with epidural boluses. Adjuvant drugs were administered as per routine clinical practice and their use compared between the groups.
For patients randomized to the CI-Sugammadex group, intravenous infusion of 0.3 mg/kg/hr (organon product insert) will be administered 30 minutes after the intubation dose or the return of PTC, whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/hr if PTC is > or < than 1-2 and adequate muscle relaxation is maintained throughout the surgery. A dose of Sugammadex (4 mg/kg) will be administered at the end of the surgery (last stitch).
For patients allocated to IB-Neostigmine group, a bolus of Rocuronium at a dose of 10mg will be administered after reappearance of TOFC > 2 and depth of neuromuscular blockade will be maintained at TOFC of 1-2. At the end of surgery, a dose of Neostigmine (50mcg/kg) will be given at the reappearance of TOFC of 2.
Rescue boluses of Rocuronium will be given if clinically indicated regardless of the depth of neuromuscular block appear on the TOF-watch.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 - 75 years old; ASA I - III;
- •Elective or Semi-Emergency Laparotomy under general anaesthesia needed tracheal intubation and muscle relaxation;
排除标准
- •Severe renal impairment (CrCL < 30 ml/ min);
- •Severe hepatic impairment;
- •BMI > 30 kg m2;
- •Known or suspected neuromuscular disorders;
- •Allergies to narcotics, muscle relaxant, benzodiazepine or other medication used during general anesthesia;
- •Hypersensitivity to the active substance or to any of the excipients
- •Patient where difficult intubation was anticipated during physical examination;
- •Patient who is contraindicated to epidural analgesia;
- •Patient on aminoglycoside antibiotics, anticonvulsants or magnesium, as it will interfere with the action of rocuronium;
- •Female patient who were pregnant, breastfeeding, or of child bearing potential and not using adequate contraception;
- •Patient with poor GCS and mental derangement who is unable to give consent.
研究组 & 干预措施
IB-neostigmine
subject will be given intermittent bolus of rocuronium during the surgery and reversal of neostigmine at the end of surgery at TOF 2
干预措施: Neostigmine, atropine (Drug)
CI-Sugammadex
subject will be given continuous infusion of rocuronium and reversal of sugammadex at the end of surgery at PTC 1-2
干预措施: Sugammadex (Drug)
结局指标
主要结局
speed of reversal
时间窗: patient monitored till return of full muscle power usually within 30 mins
Time from start of administration of reversal agent to recovery of the T4/T1 ratio to 0.9.
次要结局
- incidence of residual neuromuscular blockade(1 hour)
- Vital signs, i.e. heart rate and blood pressure(first 24 hours of post op period)
- intraoperative events(throughout the operation averagely 3 hours)
研究者
Maria Lee
Consultant Anaesthesiologist, principal investigator
Hospital Sultanah Aminah Johor Bahru