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临床试验/CTRI/2019/01/017329
CTRI/2019/01/017329已完成1 期

A Randomised Controlled Trial Comparing the procedural sedative and analgesic actions of ketofol and etofen during procedures in the emergency department

Department of Emergency Medicine Bangalore Baptist Hospital Bellary road Hebbal Bangalore1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年1月2日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
1) Pain severity (visual analogue scale) 2) Adequacy of sedation and analgesia between two groups (Modified Ramsay Sedation Score) 3) Incidence of airway adverse events

研究概览

简要总结

Procedural sedation and analgesia is the technique of administering sedatives or dissociative agents with or without analgesics to induce an altered state of consciousness that allows the patient painful and unpleasant procedures while preserving cardiorespiratory function.Recommended drugs for PSA propofol, ketamine, ketofol, alfentanyl,etofen.Procedures done commonly in emergency room include  fracture reductions, intercostal tube drainage insertions, incision and drainage of abscess and other painful procedures requiring sedation and analgesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients who decided to receive PSA for procedures and ASA physical status 1 or 2.

排除标准

  • Hypersensitivity to Ketofol or Etofen 2)Age less than 18 years 3)ASA 3 and 4.

结局指标

主要结局

1) Pain severity (visual analogue scale) 2) Adequacy of sedation and analgesia between two groups (Modified Ramsay Sedation Score) 3) Incidence of airway adverse events

时间窗: 5 minutes

次要结局

  • To compare the other adverse effects between two groups (additional drug needed, sedation duration, sedation level and patient pain and physicians satisfaction scores) 2) To determine the alterations in hemodynamic changes between two groups

研究者

发起方
Department of Emergency Medicine Bangalore Baptist Hospital Bellary road Hebbal Bangalore
申办方类型
Private hospital/clinic

研究点 (1)

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