Impact of Deep Neuromuscular Block Versus Inhalation and Total Intravenous Anesthesia (TIVA) on Laparoscopic Surgical Workspace Defined as Insufflated Pneumoperitoneum Volume.
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
- 否
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
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
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
干预措施: Sevoflurane (Drug)
remifentanyl
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
Jan Mulier
Jan Paul J Mulier MD PhD
AZ Sint-Jan AV
