Deep vs Moderate Neuromuscular Blockade on Surgical Conditions and Quality of Recovery in Day Case Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of recovery
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of its ability to improve postoperative quality of recovery (QOR) and significantly reduce hospital stay .
详细描述
Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of its ability to improve postoperative quality of recovery (QOR) and significantly reduce hospital stay.
The surgeon requires a good surgical conditions to perform the operation, whereas the anesthesiologist is concerned with postoperative QOR. Pneumoperitoneium -associated expansion of the abdominal cavity during LC is related to postoperative pain.
and other physiological changes, affecting the postoperative QOR negatively . Poor postoperative QOR leads to prolonged hospital stay .
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and II
排除标准
- •Neuromuscular disorders
研究组 & 干预措施
Deep block
In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery.
干预措施: Rocuronium Bromide (Drug)
Moderate block
In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery.
干预措施: Rocuronium Bromide (Drug)
结局指标
主要结局
Quality of recovery
时间窗: 24 hours postoperative
Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent
Surgical conditions
时间窗: Intraoperative
The surgeon assessed surgical condition every 10 minutes
次要结局
- Postoperative pain(During the length of hospital stay post surgery (on average 24 hours))
研究者
Wahba bakhet
Lecturer
Ain Shams University