Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 主要终点
- Recovery of T1 to 90%
研究概览
简要总结
This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that is characterized by short operation time, required intense paralysis and ambulatory setting, has not been investigated.
详细描述
Laser microlaryngeal surgery (LMS) requires brief and intense paralysis in the short operation time and the ambulatory setting.
The ideal muscle relaxant with rapid onset time, short duration of action and minimal side effects is not yet available.
Succinylcholine (SCC) is commonly used muscle relaxant for LMS because of its rapid onset time and short duration of action.
The use of SCC for tracheal intubation is usually followed by repeated small boluses or drip of SCC or small boluses of nondepolarizing muscle relaxants with intermediate duration.
As an alternative to SCC, the non-depolarizing neuromuscular blocking agent rocuronium can be used for LMS. The onset of rocuronium 1mg/kg is around 60s that is similar to SCC. However higher doses of rocuronium have a long duration of action; this is inappropriate in ambulatory surgery that requires rapid recovery of neuromuscular function and rapid turnover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •American Society of Anesthesiologist[ASA] class 1-3
- •scheduled Laser microlaryngeal surgery under general anesthesia
- •written informed consent
排除标准
- •suspected difficult tracheal intubation
- •disorder affecting neuromuscular blockade
- •known or suspected significant renal dysfunction
- •known or suspected severe hepatic dysfunction
- •history of malignant hyperthermia
- •allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- •contraindication to pyridostigmine and/or atropine
- •pregnancy
- •breast feeding
- •body mass index > 27kg/m2
研究组 & 干预措施
R-S group
Rocuronium-Sugammadex group
- Induction of anesthesia : 1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg
- Muscle relaxant agent : Rocuronium 1mg/kg
- After endotracheal intubation : normal saline(0.025 ml/kg)
- Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Rocuronium 0.15mg/kg
- Relaxant agent reversal. at the the end of surgery : sugammadex 2mg/kg
干预措施: Sugammadex (Drug)
S-C-N group
Succinylcholine-Cisatracurium-Neostigmine group
- Induction of anesthesia :1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg
- Muscle relaxant agent :Succinylcholine 1mg/kg
- After endotracheal intubation : Cisatracurium 0.08mg/kg
- Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Succinylcholine 10mg
- Relaxant agent reversal at the appearance of second TOF twitch (T2) : Neostigmine 0.2mg/kg with atropine 10 mcg/kg (for preventing side effects of neostigmine)
干预措施: Neostigmine (Drug)
结局指标
主要结局
Recovery of T1 to 90%
时间窗: from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes
we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Surgical Rating Score
时间窗: during surgery
describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions
Addition of Neuromuscular Blocking Agents
时间窗: during surgery
Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery
Recovery of T1 to 10%
时间窗: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes
we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
次要结局
- Time to First Spontaneous Breath(from end of surgery to first spontaneous breaths)
- Time to Eye Opening(from end of surgery to opening of the eyes to verbal commands)
- Time to Extubation(from the end of surgery to extubate a tracheal tube)
研究者
Seol Ju, Park
Resident
Korea University Anam Hospital