Laparoscopic Surgery and Abdominal Compliance Factors Including Neuromuscular Blocking Agents
试验速览
- 阶段
- 4 期
- 发起方
- CHU de Reims
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Volume of pneumoperiteum laparoscopic workspace
研究概览
简要总结
The objective of the study is to describe factors influencing abdominal compliance during laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance is measured by pressure/volume relationship.
详细描述
Background and rationale. Abdominal laparoscopic surgery is widely used. The meet good conditions, the surgeons need a large enough workspace. Carbonic gaz is insufflated in the intraperitoneal space but limited by the induced pressure which usually must not be above 15mm mercury (Hg) because of subsequent organ failures. The relationship between pressure and gaz volume insufflated defines the abdominal compliance (ΔV/ΔP).
The use of neuromuscular blocking agents (NMBA) is often used during abdominal laparoscopic surgery in order to reduce abdominal tonus, create a sufficient laparoscopic workspace hence improving abdominal compliance. However, considering good working conditions could be achieved by the use of NMBA, other factors could be considered like body weight, length, BMI, surgical abdominal history, parity.
Main objective : To compare the working surgical conditions and the pneumoperitoinea volume obtained during abdominal laparoscopic surgery with and without initial NMBA use.
Hypothesis: The use of NMBA improve the incidence of good surgical working conditions.
Study Design : Randomized blinded clinical trial. Two patients groups are compared, one receiving NMBA and one receiving a placebo. Randomisation will be realised by 1/1 ratio in blocks of 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective abdominal laparoscopy (cholecystectomy, colectomy, gastric bypass, sleeve gastrectomy, hepatic resection, splenectomy, hernial surgery, explorative laparoscopy)
- •patients who accept the protocol and sign it
- •patients affiliated at the social security
排除标准
- •formal indication of NMBA use (predictive difficult tracheal intubation, predictive difficult facial ventilation)
- •patients who needs a crush induction
- •NMBA allergia
- •patients who present a contraindication to the propofol or sufentanil
- •pregnancy
- •breastfeeding womens
- •patients protected by the law
研究组 & 干预措施
NMBA group
干预措施: laparoscopic surgery (Procedure)
placebo group
干预措施: propofol (Drug)
NMBA group
干预措施: propofol (Drug)
NMBA group
干预措施: NMBA - cisatracurium (Drug)
NMBA group
干预措施: sufentanil (Drug)
placebo group
干预措施: placebo - isotonic saline serum (Drug)
placebo group
干预措施: sufentanil (Drug)
placebo group
干预措施: laparoscopic surgery (Procedure)
结局指标
主要结局
Volume of pneumoperiteum laparoscopic workspace
时间窗: Day 0 (after anesthesia induction)
laparoscopic workspace assessed by volume of pneumoperiteum \> 3 Liters
score SRS (Surgical Rating Scale)
时间窗: Day 0 (after anesthesia induction)
次要结局
未报告次要终点