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临床试验/NCT04582032
NCT04582032已完成不适用

Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
The injection pain due to rocuronium

研究概览

简要总结

Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.

0;No movement response to injection

  1. Mild movement response to injection
  2. Hand withdrawal response to injection
  3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.

Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

详细描述

Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.

0;No movement response to injection

  1. Mild movement response to injection
  2. Hand withdrawal response to injection
  3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.

Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • non allergic to dexketoprofen
  • 18-60 years old
  • American Society of Anesthesiologists(ASA) 1-2-3
  • 70-90 kg weigh

排除标准

  • patients with psychiatric and mental problems

研究组 & 干预措施

Dexketoprofen group,

Active Comparator

IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction

干预措施: Dexketoprofen (KETAVEL 50 mg/2 ml) (Drug)

Saline group

Other

IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction

干预措施: Saline (Isotonic Saline Solution 0.9% ) (Drug)

结局指标

主要结局

The injection pain due to rocuronium

时间窗: 1 month

Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

次要结局

  • Score on pain due to injection of rocuronium(1 month)

研究者

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

Mehmet sahap

Assistant professor

Ankara City Hospital Bilkent

研究点 (1)

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