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临床试验/NCT05031676
NCT05031676已完成不适用

Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery

Université NAZI BONI1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Highest numerical pain score

研究概览

简要总结

Opioid free anesthesia is a promising practice in anesthesia. Studies already carried out have compared OFA to an opioid or "opioid anesthesia" (OA) protocol without the use of antihyperalgesic in the OA protocol. Most of the studies currently available have been carried out in Europe, America and a few in Asia under conditions other than those available in precarious situations.That's why we decide to conduct a study to evaluate the effectiveness of an OFA protocol in maxillofacial surgery in Burkina Faso.

详细描述

The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso

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
Single (Participant)

盲法说明

Participant does not know the protocol which receive but i

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged between 15 and 65 years, admitted to the central operating room of the hospital for maxillofacial surgery.

排除标准

  • Known or suspected coronary artery disease on preoperative consultation;
  • Unstable arterial hypertension
  • Insulin-dependent diabetes
  • Second degree atrioventricular block
  • Neuro-vegetative dysautonomia;
  • known allergy or intolerance to a drug of the protocols

结局指标

主要结局

Highest numerical pain score

时间窗: First two hours postoperatively

The main highest numerical pain score postoperatively

次要结局

  • Wake up(Time between the end of surgery and extubation)
  • Nausea-Vomiting(During 24 after surgery)
  • Highest numerical pain score 24 hours(The first 24 hours postoperatively)
  • Heart rate(six minutes after incision)
  • Blood pressure(six minutes after incision)
  • Ephedrine(During anesthesia)
  • Non-surgical complications(During 24 hours after surgery)

研究者

发起方
Université NAZI BONI
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismael Guibla

Anaesthesist

Université NAZI BONI

研究点 (1)

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