Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less
研究概览
简要总结
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.
The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.
详细描述
The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients older than 18 years
- •Scheduled for elective laparoscopic cholecystectomy
- •Can read and understand danish
- •Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives
排除标准
- •Known allergy to medications that are included in the project
- •Presence of severe renal disease, neuromuscular disease, reduced liver function
- •Nursing or pregnant
- •Indication for crash induction
- •For fertile women: Missing negative pregnancy-test
研究组 & 干预措施
Deep neuromuscular blockade
干预措施: Rocuronium (Drug)
Moderate neuromuscular blockade
干预措施: Rocuronium (Drug)
结局指标
主要结局
The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less
时间窗: From surgical incision to last suture has been placed, an expected average of 30 minutes
The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.
次要结局
- Surgical Space Conditions(During dissection of the gallbladder)
- Pain(At arrival to the postanesthesia care department, 2 hours and 1 day after surgery)
- Normal Functional Level(from the day of surgery to re-establishing normal functional level - an expected average of 7 days.)
- Surgical Procedures at Low Pneumoperitoneum(From surgical incision to last suture has been placed, an expected average of 30 minutes.)
- Duration of Surgery(From surgical incision to last suture has been placed.)
- Duration of Anesthesia(From induction of anesthesia to patient ready to leave the operating theatre)
- Consumption of Analgesics(The first 24 hours after surgery)
- Nausea and Vomiting(The first 24 hours after surgery)
- Anti-emetics(During the first 24 hours after surgery)
研究者
Anne Kathrine Staehr-Rye
Clinical research assistent
Herlev Hospital