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临床试验/NCT01946763
NCT01946763Unknown不适用

Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?

Procare Riaya Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Quality of anesthesia recovery

研究概览

简要总结

The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications).

In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.

详细描述

The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.

Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.

Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.

Recovery assessment and data recording is done by a blinded anesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults more than 18 years old.
  • BMI more than
  • scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.

排除标准

  • Renal impairment.
  • Hepatic dysfunction.
  • Alcohol or drug abuse.
  • Disabling Central nervous or cerebrovascular diseases.
  • Treatment with opioids or any psychoactive medication.
  • Inappropriate Mini mental state exam.

结局指标

主要结局

Quality of anesthesia recovery

时间窗: 6 hours

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

Ahed ZEIDAN

Anesthesiologist

Procare Riaya Hospital

研究点 (2)

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