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临床试验/NCT02812186
NCT02812186已完成4 期

Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery

Stony Brook University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年12月27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
入组人数
79
试验地点
1
主要终点
Peak Airway Pressures

研究概览

简要总结

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

详细描述

Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.

Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.

Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • Each participant must be willing and able to provide written informed consent for the study.
  • Each participant must be American Society of Anesthesiologists (ASA) class I, II or III.
  • Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery).
  • Expected surgical duration of 60 min or longer

排除标准

  • Inability to give informed oral or written consent
  • Known or suspected neuromuscular disorders impairing neuromuscular function;
  • True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids
  • A history (patient or family) of malignant hyperthermia
  • A contraindication for neostigmine administration
  • Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level
  • Body mass index >40 kg/m^2
  • Significant respiratory disease.
  • Planned postoperative mechanical ventilation

研究组 & 干预措施

Deep to Moderate NMB

Other

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

干预措施: Deep to Moderate NMB (Procedure)

Deep to Moderate NMB

Other

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

干预措施: Rocuronium (Drug)

Moderate to Deep NMB

Other

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

干预措施: Moderate to Deep NMB (Procedure)

Moderate to Deep NMB

Other

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

干预措施: Rocuronium (Drug)

结局指标

主要结局

Peak Airway Pressures

时间窗: Intra-operative, from intubation time to extubation time

To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB

次要结局

  • Abdominal Insufflation Pressure(Intra-operative, from intubation time to extubation time)
  • Surgical Rating Scale(Intra-operative, from intubation time to extubation time)

研究者

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

Ruchir Gupta

Clinical Assistant Professor

Stony Brook University

研究点 (1)

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