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临床试验/NCT02529501
NCT02529501已完成不适用

Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery

Nordic Pharma SAS1 个研究点 分布在 1 个国家目标入组 595 人开始时间: 2015年7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
595
试验地点
1
主要终点
Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia

研究概览

简要总结

The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery.

详细描述

This is a cross-sectional, observational, prospective, multicentre study, conduct in France among a representative sample of anesthesiologists.

The factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) will be assessed in patients undergoing an outpatient surgery. Data will be collected by the physician during the inclusion visit (peripostoperative consultation). Additional data regarding the patient's perception (pain and satisfaction) will be collected using a self-questionnaire 7 days after the surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adult patients undergoing an ambulatory surgery
  • Patients for whom either a spinal anesthesia or a short general anesthesia is planned
  • Patients accepting and able to complete a self-administered questionnaire in French language
  • Informed patients who accept the computer processing of their medical data and their right of access and correction

排除标准

  • Patients with contra-indications to elective ambulatory surgery
  • Emergency surgeries
  • Patient for which both spinal anesthesia and short general anesthesia coexist
  • Patients with contra-indications to spinal anesthesia (due to surgical procedure site, comorbidities or patient's treatment)
  • Patients participating or having participated in the previous month in a clinical trial in anaesthesiology

结局指标

主要结局

Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia

时间窗: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit

All proposed factors will be described using a 4-levels verbal scale (decisive / important / of little importance / unimportant). The factors will be described from the questionnaire completed by the investigator during the inclusion visit, before the surgery. Decisive factors for the choice of anesthesia will be described and compared between the two subgroups.spinal anesthesia and short general anesthesia.

次要结局

  • Use and safety of Baritekal® (prilocaine) if applicable(During surgery)
  • Patients' characteristics in each subgroups(At the time of the perioperative consultation prior to their surgery (start of the inclusion visit or baseline visit))
  • Patients' pain according to the type of anesthesia using a VAS scale(Up to 7 days after surgery)
  • Costs of spinal and general anesthesia(The day of the surgery)
  • Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia(Up to 24h after the surgery)
  • Patients' satisfaction according to the type of anesthesia based on 2 questions using a 4-levels verbal scale(7 days after surgery (i.e. 7 days after the inclusion))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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