Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- physiological domain of PQRS recovery
研究概览
简要总结
Sugammadex has been approved as the first targeted reversal binding agent providing predictable and complete reversal of neuromuscular blockade induced by rocuronium or vecuronium, and achieving so with a favourable safety profile.
Its benefits over traditional acetylcholinesterase inhibitors have been widely demonstrated in many studies. The scope of such studies has been mostly related to the efficacy of NMB reversal and safety. However, the clinical use of sugammadex led some anaesthesiologists to observe that following the use of this agent, patients seemed to recover consciousness faster and look like they were feeling better. To present, there is little information on the effect of sugammadex on awakening from anaesthesia.
The quality of postoperative recovery focused around patient-oriented endpoints has raised new interest as a measure of the quality of anaesthesia and a target towards which improvement can be directed.
On the other hand, there is no single prospective study performed to address a possible effect of sugammadex on recovery from anaesthesia.
The objective of this study was to compare the effect of sugammadex and neostigmine on the quality of postoperative recovery using the PQRS in elderly patients undergoing trans pars plana vitrectomy with general anesthesia
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia
排除标准
- •Neuromuscular disease
- •History of malignant hyperthermia
- •Significant renal or hepatic dysfunction
- •Allergy to sugammadex or rocuronium
- •BMI > 30kg/m2
- •History of medication which affect neuromuscular blocker such as anti-convulsants, magnesium
研究组 & 干预措施
Sugammadex group
After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
干预措施: Sugammadex (Drug)
Neostigmine group
After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.
干预措施: Neostigmine (Drug)
结局指标
主要结局
physiological domain of PQRS recovery
时间窗: at 40 min after the end of surgery
The primary objective of the study was to assess the physiological domain of PQRS recovery from anesthesia for patients treated with neostigmine and those given sugammadex at 40 min after the end of surgery. Recovery was defined as return (or improvement from) baseline values.
次要结局
- overall PQRS recovery and recovery in the different domains of the PQRS(The secondary objective of the study was to compare the overall PQRS recovery and recovery in the different domains of the PQRS between neostigmine and sugammadex treated patients at 15 min , 40 min , 1 day after the end of surgery.)