Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Quality of Recovery(QoR)-15 questionnaire score
研究概览
简要总结
The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.
详细描述
Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort, Physiological support, Physical independece, Pain), and is a proven method of reliability, consistency and validity for evaluating recovery from surgery and anesthesia.
After laparoscopic cholecystectomy, patients experience various discomforts such as pain, nausea, vomiting, and placebo due to general anesthesia.
Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition, residual neuromuscular blockade was higher in neostigmine compared with sugammadex.
Although sugammadex expected to improve patient's recovery, it is still controversial that sugammadex contributes to clinically meaningfull difference compared with neostigmine.
Therefore, the aim of our study is comparison of quality of recovery through QoR-15 questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and neostigmine in laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent laparoscopic cholecystectomy aged 20-70
排除标准
- •neuromuscular disease
- •allergy to rocuronium, sugammadex, neostigmine
- •cognitive impairment ( disable to answer the questionnaire )
- •refuse to participate
研究组 & 干预措施
sugammadex
sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)
干预措施: Sugammadex (Drug)
neostigmine
with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)
干预措施: Neostigmine (Drug)
结局指标
主要结局
Quality of Recovery(QoR)-15 questionnaire score
时间窗: preoperative 1 days to postoperative 2 days
the difference of Quality of Recovery(QoR)-15 score between preoperative and postoperative 1 and 2 days (minimum value : 0, maximum value : 150, the higher the score, the better the result)
次要结局
- postoperative pain score(at postoperative 30minutes, 6hours, 24hours)
- the incidence of administration of postoperative rescue drug(perioperative - until 72hours)
- hospital stay(preoperative - until discharge (usually 48 hours to 72hours))
- urinary retention(postoperative - until discharge (usually 48 hours to 72hours))
- recovery time(perioperative - until 48hours)
- PACU(post-anesthesia care unit) stay time(perioperative - until 48hours)
研究者
JiWon Han
clinical instructor
Seoul National University Bundang Hospital