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临床试验/NCT04466943
NCT04466943Unknown不适用

The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia: A Randomized Double Blinded Clinical Trial

King Saud University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
Complete recovery in post anesthesia care unit (PACU) without residual curarization

研究概览

简要总结

Most published articles suggest that deep neuromuscular blockade is required for bariatric surgery. However, the evidence for such practice is still inconclusive. From the clinical experience at a major bariatric center of volume exceeding six hundred procedures annually, the investigators believe that moderate neuromuscular blockade will provide an adequate surgical condition and significantly facilitate enhanced recovery after bariatric procedures.

详细描述

Muscle relaxation is paramount for successful laparoscopic surgery. However the optimal degree of neuromuscular blockade (NMB) is not identified yet. Previous studies showed conflicting results on the outcomes of laparoscopic surgical conditions when moderate NMB was compared to deep blockade .The evidence for the use of either modalities is rather limited . In the recent literature, there is insufficient evidence to conclude that deep NMB improves surgical conditions during laparoscopic bariatric surgery.

In the recent literature, there is insufficient evidence to conclude that deep NMB improves surgical conditions during laparoscopic bariatric surgery. However postoperative pulmonary function was decreased independently of the depth of NMB regime. There are limited data on the effect of such practices on postoperative outcomes especially in enhanced recovery after bariatric anesthesia (ERABA) .A previous study by Unterbuchner C has showed deep NMB may improve surgical conditions during low-pressure capnoperitoneium , However ,it has also been reported by M.H. Bruintjes and his colleagues showed that the routine capnoperitoneium insufflation pressure improved surgical conditions independent of the level of muscular relaxation. Torensma B and his colleagues have reported that the previous pregnancy can affects the abdominal wall strength and eventually the degree of relaxation Therefore, the investigators have decided to exclude any females with previous history of pregnancy in the study design and also report interaction between inhalation anesthetics and NMB, through augmentation of the effect of NMB.

Martini and his colleagues showed that , rating of the quality of surgical conditions considerably varies between different surgeons when assessed through Leiden-Surgical-Rating-scale . Therefor in this study, the Lieden-surgical-score is going to be used by the bariatric surgeon who is going to be the operating consultant in this study population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Only the attending anesthesiologist and anesthesia assistant are going to be aware of the allocation in order to administer the required level of NMB

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age older than 18 years.
  • Obese or morbidly obese as defined by a BMI > 35 (kg/m2).
  • American Society of Anesthesiologists physical status class II, or III.
  • Presenting of Laparoscopic sleeve gastrectomy.

排除标准

  • History of allergy to Rocuronium or Sugammadex.
  • History of allergy to Dexamethasone, Ondansetron, Paracetamol, Fentanyl, Propofol, Morphine or Tramadol.
  • Current or previous pregnancy.
  • History of renal impairment, (We are going to use the Cockcroft-Gault equation is the gold standard for estimating renal function for the purposes of drug dosing cut off point: CrCl/GFR=30ml/min) The GFR calculator is available at: http://clincalc.com/Kinetics/CrCl.aspx?example
  • Patient on oxygen therapy , e,g CPAP

结局指标

主要结局

Complete recovery in post anesthesia care unit (PACU) without residual curarization

时间窗: immediate postoperative in the PACU

clinical signs of recovery are met in the PACU

次要结局

  • Complete recovery in the ward(first postoperative day)

研究者

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

Narjes Sultan AL-Otaibi

Principal Investigator

King Saud University

研究点 (2)

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