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临床试验/NCT03170661
NCT03170661已完成4 期

Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年6月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Leiden Surgical Rating Scale

研究概览

简要总结

A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.

详细描述

Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
  • American Society of Anesthesiologists (ASA) class I-III
  • > 18 years of age;
  • Ability to give oral and written informed consent.

排除标准

  • 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 glomerular filtration rate < 30 ml/h creatinine.
  • Previous retroperitoneal surgery at the site of the current surgery.
  • Body mass index > 35 kg/m2

研究组 & 干预措施

Deep neuromuscular block

Experimental

Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count

干预措施: Deep neuromuscular block (Drug)

结局指标

主要结局

Leiden Surgical Rating Scale

时间窗: during surgery

During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported.

次要结局

  • Postoperative Measurements and Outcomes; Pain Scores(During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals)
  • Intraoperative Nociception Level(Perioperative measurements at 15 minute interval (on average during 3 hours))
  • Intraoperative Hemodynamic Conditions(Perioperative measurements at 15 minute interval (on average during 3 hours))
  • Postoperative Measurements and Outcomes; Saturation(During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals)
  • Postoperative Measurements and Outcomes; Sedation Levels(During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Dahan

Clinical professor

Leiden University Medical Center

研究点 (1)

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