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临床试验/NCT01930747
NCT01930747已完成4 期

Impact of Deep Neuromuscular Block Versus Inhalation and Total Intravenous Anesthesia (TIVA) on Laparoscopic Surgical Workspace Defined as Insufflated Pneumoperitoneum Volume.

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年4月最近更新:
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
50
试验地点
1
主要终点
Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by

研究概览

简要总结

The objective of this study is to compare the value of deep neuromuscular block (NMB) (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.

The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points allow to calculate the abdominal compliance and the pressure at zero volume (PV0).

详细描述

Background and rationale

The value of administering a deep neuromuscular block (NMB) to reach a post-tetanic count (PTC) of < 4 during laparoscopy is not clear. Some anesthesiologists claim that certain laparoscopic procedures do not need NMB at all and that surgeons cannot objectivize the existence of insufficient workspace and the effect of NMB. They assume that deep anesthesia with remifentanyl improves also the workspace. This assumption may be based on the fact that deep anesthesia prevents spontaneous active muscle contractions. However, preventing an active contraction through deep anesthesia is different from blocking the "active tonus" with a NMB.

Due to the difficulties in evaluating the surgical access, surgical workspace (1) should be measured as the inflated carbon dioxide (CO2) volume for a given intra-abdominal pressure during pneumoperitoneum. Abdominal compliance (C or its reciprocal the elastance: E) and the pressure at zero volume (PV0) are calculated by measuring three or more pressure volume points to construct the abdominal pressure volume relation.

The objective of this study is to compare the value of deep NMB (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 Minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.

Objectives

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

排除标准

  • Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
  • History of a laparotomy
  • Emergency laparoscopy

研究组 & 干预措施

deep neuromuscular block

Experimental

deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given

干预措施: rocuronium (Drug)

inhalation with 1 MAC Sevoflurane

Experimental

1 MAC Sevoflurane inhalation is given after first measurement of lap workspace

干预措施: Sevoflurane (Drug)

remifentanyl

Experimental

remifentanyl infusion is given after first measurement of lap workspace

干预措施: remifentanyl (Drug)

结局指标

主要结局

Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by

时间窗: 5 min after reaching 1 MAC or haven given the anesthetics intravenous

the impact of the following agents on the abdominal elastance (E) : remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).

Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen

时间窗: 5 min after reaching 1 MAC or haven given the anesthetics intravenous

the impact of the following agents on the pressure at zero volume (PV0): remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).

次要结局

  • Adverse Events Difference Between the Three Groups(from zero till 24 hours after recovery of surgery.)

研究者

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

Jan Mulier

Jan Paul J Mulier MD PhD

AZ Sint-Jan AV

研究点 (1)

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