A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Time for recovery from moderate NMB
研究概览
简要总结
The aim of this study is to compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade.
详细描述
Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists for general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Unfortunately, postoperative residual neuromuscular blockade (rNMB), is an adverse event usually observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications.To prevent those complications, monitoring NMBAs activity as well as appropriate reversal are crucial.
In the light of the strong evidence proving the superiority of sugammadex for the reversal of NMB, the investigators chose to examine whether a quarter dose (0.5 mg.kg-1) of sugammadex would be superior to neostigmine for the reversal of moderate NMB (TOF 1 to 3). The investigators believe that this strategy will encourage the routine use of sugammadex because of a drastically reduced cost per patient with an increased safety and less adverse events compared to neostigmine reversal.
This study will be conducted in a single center, double blinded, randomized controlled study.
Type of surgery: any surgery under general anesthesia in ASA 1-3 patients, fully consented.
In the OR, the investigators will place a standardized monitoring: ECG, non-invasive blood pressure and SpO2. The investigators will monitor the depth of anesthesia using the BIS index (Medtronic, Canada) and the intraoperative nociception balance using the NOL index (Medasense Ltd., Ramat Gan, Israel). Finally, the investigators will monitor neuromuscular blockade using TOF-scan® (Draeger, Mississauga, Canada). The stimulation electrodes will be placed on the forearm of the patient to monitor the response to ulnar stimulation of the adductor pollicis muscle.
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)
盲法说明
Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex. Group N will receive the standard reversal (neostigmine 50 µg.kg-1 and glycopyrrolate 7 µg.kg-1) and group S will receive sugammadex 0.5 mg.kg-1. Randomization will be done prior to the entrance in the OR, the day of the surgery.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA 1-3 patients,
- •Undergoing general anesthesia with rocuronium induced NMB,
- •TOF 1-3 at the end of surgery,
- •BMI < 36 kg.m-2,
- •Age > 18 years old
排除标准
- •History of coronary artery disease and unstable before surgery
- •History of serious cardiac arrhythmia (including atrial fibrillation)
- •Renal or hepatic dysfunction
- •Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- •Neuromuscular disease
- •Allergy to any drug used in the study protocol
研究组 & 干预措施
Group "N" for Standard reversal
Standard reversal of 50 µg.kg-1 neostigmine (up to a maximum dose of 5mg) and 7 µg.kg-1 glycopyrrolate at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3.
干预措施: Neostigmine and glycopyrrolate (Drug)
Group "S" for Sugammadex
Sugammadex 0.5 mg.kg-1 IV will be performed at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Time for recovery from moderate NMB
时间窗: Intra-operative (from T0 = incision until Tend = start dressing)
Time, in minutes, for recovery of the TOF ratio to 0.9 at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery).
次要结局
- Incidence of reoccurrence of NMB(Intra-operative (from T0 = incision until Tend = start dressing))
- Vital signs changes - Heart rate(Every 15 minutes until discharge from PACU, up to 2 hours)
- PACU scores - PONV score(Every 15 minutes until discharge from PACU, up to 2 hours)
- Time for awakening and extubation(Intra-operative (from T0 = incision until Tend = start dressing))
- Incidence of critical respiratory event(Every 15 minutes until discharge from PACU, up to 2 hours)
- Vital signs changes - Mean arterial pressure(Every 15 minutes until discharge from PACU, up to 2 hours)
- Vital signs changes - Respiratory rate(Every 15 minutes until discharge from PACU, up to 2 hours)
- PACU scores - Aldrete(Every 15 minutes until discharge from PACU, up to 2 hours)
- PACU scores - Maisonneuve-Rosemont PACU score(Every 15 minutes until discharge from PACU, up to 2 hours)
- PACU scores - POSS score(Every 15 minutes until discharge from PACU, up to 2 hours)
- Time spent in PACU(Every 15 minutes until discharge from PACU, up to 2 hours)
- Overall cost(Intra-operative (from T0 = incision until Tend = start dressing) to PACU discharge, up to 2 hours)
- Vital signs changes - Oxygen saturation(Every 15 minutes until discharge from PACU, up to 2 hours)
- PACU scores - NRS pain score(Every 15 minutes until discharge from PACU, up to 2 hours)
- Cost of reversal agent(Intra-operative (from T0 = incision until Tend = start dressing))
研究者
Philippe Richebe
Director of Research, Principal Investigator, Anesthesiologist, Associate Professor, MD, PhD
Ciusss de L'Est de l'Île de Montréal