A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Percentage of Patients Recovered Cognitively at 1 Week
研究概览
简要总结
Trial summary: deep neuromuscular block is proposed as a technique to improve operative conditions for laparoscopy. Early clinical data would suggest that there may also be patient benefits beyond the operative period related to lower intra-abdominal pressure, and improved surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide moderate neuromuscular block and reverse with neostigmine. It is not possible to safely reverse deep neuromuscular block using neostogmine, as the majority of block must have worn off for neostigmine to be effective. in order to identify whether deep neuromuscular block improves quality of recovery after surgery, the investigators will conduct a randomised trial of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic techniques and drugs used. the outcome measured will be the post-operative quality of recovery over multiple time periods using the Postoperative Quality of Recovery Scale (PostopQRS). 350 patients will be enrolled over 4 centres.
详细描述
Objectives
- To identify whether the rate/quality of recovery is affected by deep neuromuscular block (DNB) and reversal with sugammadex versus light/moderate neuromuscular block reversed with neostigmine and couple with desflurane or sevoflurane in patients undergoing operative gynecological or abdominal laparoscopic surgery of at least 1-hour duration.
Hypothesis
- The technique of deep neuromuscular block and reversal with sugammadex will result in improved quality of recovery, including cognition, compared to the current standard of care technique using light/moderate neuromuscular block reversed with neostigmine in patients undergoing operative gynecological or abdominal laparoscopic surgery of at least 1-hour duration.
Background:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants
- •operative gynecological or abdominal surgery
- •receiving general anesthesia
- •Operation expected to exceed1 hour duration
- •Participants must speak sufficient English to answer the survey questions
排除标准
- •Participants undergoing diagnostic laparoscopy only
- •Participants <18 years of age
- •Current pregnancy
- •Known allergy to rocuronium, neostigmine or sugammadex, or desflurane
研究组 & 干预措施
ModNMB
Moderate Neuromuscular block: participants will receive moderate neuromuscular blockade with rocuronium aiming for TOF 0-2 twitches, with neostigmine reversal when the TOF at least 3 twitches. The depth of neuromuscular block may be reduced after completion of the majority of surgical excision to TOF 3 or more
Neostigmine
干预措施: Neostigmine (Drug)
DeepNB
Deep Neuromuscular block: participants will receive DNB aiming for a post tetanic count of 1-2, which will be maintained until removal of the laparoscopic ports, with reversal using sugammadex
干预措施: Sugammadex (Drug)
结局指标
主要结局
Percentage of Patients Recovered Cognitively at 1 Week
时间窗: 1 week
The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.
次要结局
- Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation(3 months)
- Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation(6 hours)
- Duration of Anesthesia From Induction to Cessation of the Anesthetic(Up to 6 hours)
- Number of Participants Categorized by Level of Surgical Satisfaction(2 hours)
- Duration of Hospital Length of Stay(3 days)
研究者
Colin Royse
Professor of Anesthesia
University of Melbourne