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临床试验/NCT02300168
NCT02300168已完成不适用

Neuromuscular Blockade as a Determinant of Surgical Outcome and Post-operative Recovery, in Patients Undergoing Elective Laparoscopic Bariatric Surgery

Hopital du Sacre-Coeur de Montreal0 个研究点目标入组 50 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
surgeon evaluation of working surgical conditions

研究概览

简要总结

The aim of the current observational study is to better assess the relationships between neuromuscular blockade and multiple surgical outcomes in patients undergoing elective laparoscopic bariatric surgery.

详细描述

Performing bariatric surgery as a short-stay procedure is an ongoing trend in many centers around the world. For morbidly obese (MO) patients, the anesthetic approach is based on choosing drugs that have the least potential for accumulation. This allows a more rapid and clear-headed recovery and contributes to reduced duration of perioperative time. However, when neuromuscular blockade (NMB) is required during surgery, complete recovery is a major factor that may prevent from a rapid fast-track discharge.

In Canada, reversal of NMB is achieved by using acetylcholinesterase (AChE) inhibitors, mostly neostigmine, which must be administered after a certain level of spontaneous recovery in order to ensure a complete reversal. This elongates the time spent in the operating room (OR), and prevent therefore from a fast track surgery procedure. On the other hand, in an effort to shorten the time spent in the OR, AChE inhibitors may sometime be administered too early before spontaneous recovery, and post-operative residual curarization (PORC) may then be observed. In the post-anesthesia care unit (PACU), PORC may be particularly problematic, because of the possible occurrence of critical respiratory events (CREs). This in turn is also associated with significant delayed discharges.

Because of the aforementioned inconveniences, Canadian anesthesiologists are reluctant to induce deep NMB. Consequently, intra-abdominal pressure remain non optimal during the surgery, which do not facilitate the surgeons work, in addition to increase perioperative time. This problem is particularly frequent in cases of bariatric surgeries.

The current study will explore this question from the perspective of the surgeon satisfaction and the patient quality of recovery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • MO patients [body mass index (BMI)≤ 55kg/m2] scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

排除标准

  • a physical status >3 (ASA),
  • a difficult tracheal intubation,
  • a known or suspected disorder affecting NMB,
  • a renal, pulmonary, cardiac, and/or hepatic dysfunction,
  • malignant hyperthermia,
  • pregnancy, breastfeeding,
  • allergy or contraindication to narcotics, rocuronium, neostigmine, or other medications used during anesthesia
  • patients with sleep apnea syndrome will also be excluded.

结局指标

主要结局

surgeon evaluation of working surgical conditions

时间窗: intraoperative

the surgeon will score the surgical working conditions at 15 min intervals, according to a 5-point ordinal scale

次要结局

未报告次要终点

研究者

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

Pierre Garneau

Chief, General Surgery Department

Hopital du Sacre-Coeur de Montreal

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