NCT01628952已完成4 期
Comparison of the Bilateral Transversus Abdominis Plane (TAP) Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle relaxation.
研究概览
简要总结
This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and under 75 years
- •Informed consent signed
- •ASA I, II and III
- •Patient affiliated to social security
排除标准
- •BMI> 35 kg / m
- •Personal or family history of malignant hyperthermia
- •History of allergy or hypersensitivity to intravenous anesthetics (remifentanil), local anesthetics or muscle relaxants
- •Contraindications to sevoflurane: a history of malignant hyperthermia, history of liver disease after sevoflurane anesthesia, halogenated agents or hypersensitivity to any of these components.
- •Contraindications to succinylcholine: hyperkalemia, plasma cholinesterase deficiency nickname, para or tetraplegia more than 24 hours, burns over 24
- •Contraindications to cisatracurium: myasthenia
- •Neuromuscular diseases
- •Contraindications to local anesthetics: hypersensitivity to local anesthetics of the amide, intravenous regional anesthesia, porphyria, ventricular atrial conduction disturbances, epilepsy uncontrolled by treatment
- •Pregnancy and lactation
- •severe coagulation disorders
- •Inability to understand and give informed consent
- •Patient under guardianship, curatorship or protected
- •Indication of use of a hypnotic ketamine (BIS change)
研究组 & 干预措施
TAP
Experimental
干预措施: Transversus Abdominis Plane (Drug)
curare
Active Comparator
Patients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block
干预措施: Curare (Drug)
结局指标
主要结局
Muscle relaxation.
时间窗: 20 minutes after anesthesia induction
Muscle relaxation of the abdominal wall will be evaluated based on the amount of volume infused initially to create the pneumoperitoneum. This parameter is given by the unit of laparoscopy and allow us to calculate the abdominal compliance (C = ΔV / Ap).
次要结局
未报告次要终点
研究者
研究点 (2)
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