Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients (BLISS3)
Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Zuid Holland
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The Hague、Zuid Holland、荷兰
- Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
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Zuid-Holland
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Leiden、Zuid-Holland、荷兰
- Leiden University Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA I-III
- BMI > 34 kg/m2
- Elective bariatric surgery.
Exclusion Criteria:
- Known or suspected neuromuscular disorders impairing neuromuscular function
- Allergies to muscle relaxants, anesthetics or narcotics
- A(family) history of malignant hyperthermia
- Women who are or may be pregnant or are currently breast feeding
- Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：moderate neuromuscular block
rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
|
|
|
实验性的：deep neuromuscular block
rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical Rating
大体时间：intraoperative
|
During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported. |
intraoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Extubation
大体时间：intraoperative
|
The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).
|
intraoperative
|
|
Pain
大体时间：postoperative, for up to 2 hours
|
pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.
|
postoperative, for up to 2 hours
|
|
Respiration
大体时间：2 hours postoperative
|
Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported. |
2 hours postoperative
|
|
Mean Arterial Blood Pressure
大体时间：2 hours postoperative
|
Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported. |
2 hours postoperative
|
合作者和调查者
调查人员
- 首席研究员：Albert Dahan, MD, PhD, professor、LUMC
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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