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临床试验/NCT06045559
NCT06045559招募中不适用

Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Duration of neuromuscular block with rocuronium.

研究概览

简要总结

This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (PTC) values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.

详细描述

In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain can be reduced.

The results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent. However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.

Our primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) Ⅰ-Ⅲ patients
  • between the ages of 18-65

排除标准

  • Being under 18 of age or over 65
  • disapproval of the informed consent
  • rocuronium allergy
  • sugammadex allergy
  • pregnancy
  • lactation
  • hepatic or renal dysfunction
  • obesity (BMI≥35kg/m2)
  • Previous abdominal surgery
  • long-term use of NSAIs
  • neuromuscular disorders

结局指标

主要结局

Duration of neuromuscular block with rocuronium.

时间窗: 15 seconds for TOF rates, 8 minutes for PTC values

TOF rates will be measured every 15 seconds and PTC values will be measured every 8 minutes. Additionally, the times of TOF 0 and PTC 0 responses and TOF1 and PTC 1 responses will be recorded.

次要结局

  • intra-abdominal pressure(5 minutes)
  • postoperative pain(2nd, 24th and 72nd hours after surgery)
  • surgical conditions(It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.)
  • postoperative nausea and vomiting(postoperative 4th, 12th and 24th hours)
  • Length of extubation process(15sc)
  • Lenght of recovery process(1 mınute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selim Turhanoglu

Professor Dr.

Mustafa Kemal University

研究点 (1)

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