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临床试验/NCT05225610
NCT05225610已完成不适用

Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月19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
120
试验地点
1
主要终点
Pain Assessment

研究概览

简要总结

No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.

详细描述

Propofol is a commonly used anaesthetic for inducing general anaesthesia. Pain on propofol injection is distressing and is one of the limitations of its use. Propofol is a phenol compound, which irritates nerve endings on the venous endothelium to produce immediate pain, whereas delayed pain is mediated by the release of bradykinin. Bradykinin causes vasodilation and increases venous permeability, thereby facilitating contact of the aqueous phase of propofol with nerve endings. Delayed pain occurs 10-20 seconds after injection.

Various methods have been tried so far to reduce pain on propofol injection. A commonly used technique is lignocaine either as pre-treatment or mixed with propofol. Other methods include the use of butorphanol, ondansetron, metoclopramide, opioid, or thiopentone. Propofol injection into a large vein, pre-injection cooling, or warming of propofol have also been investigated.

The Valsalva manoeuvre is a physiological technique, used in the reduction of pain associated with several procedures. The Valsalva manoeuvre alleviates both the somatic and psychological aspects of painful procedures.

Dexmedetomidine is an alpha-2 adrenoceptor agonist that has analgesic and sedative properties, it has been evaluated for reducing the incidence and intensity of propofol-induced pain, but reported results are inconsistent.

in this study, investigators will study the effect of Valsalva manoeuvre as compared with dexmedetomidine injection in reducing the pain associated with propofol injection in upper gastrointestinal endoscopies.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Adult patients aged 30-60 years old.
  • American Society of Anesthesiologist physical status(ASA) Grade I and II.
  • Upper gastrointestinal Endoscopies.

排除标准

  • Patients with mental illness, restlessness.
  • Cardio-respiratory disease.
  • Chronic pain disorder.
  • Use of preoperative analgesic medication.
  • History of propofol allergy.
  • History of drug abuse.
  • Inability to perform the Valsalva manoeuvre. -

研究组 & 干预措施

VALSALVA Group

Experimental

40 Patients will perform the Valsalva manoeuvre before starting propofol injection by blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds and 5 ml saline will be administered in 5 seconds.

干预措施: Valsalva Manoeuvre (Other)

DEXMED Group

Experimental

40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group, patients will receive 0.5 µg/kg Dexmedetomidine diluted in 5 ml saline in 5 seconds as a sedating dose prior to injection of propofol.

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

CONTROL Group

Placebo Comparator

40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group and only 5 ml saline will be administered over 5 seconds.

干预措施: normal Saline (Drug)

结局指标

主要结局

Pain Assessment

时间窗: 20 seconds after propofol injection.

using a ruler as the visual analogue scale(VAS), The VAS score ranged from 0-10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will be instructed to mark a point on the VAS ruler that represented the intensity of pain. The pain score was determined by measuring the distance in mm between 0 (no pain) and the mark will be indicated by the patient on the ruler.

次要结局

  • Propofol injection site reaction(24 hour)
  • Withdrawal response score(20 seconds after propofol injection)
  • Heart Rate(HR) beat / minute(10 minutes)
  • Non-invasive blood pressure(NIBP) mmHg(10 minutes.)

研究者

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

AHMED ABDELAZIZ SHAMA

LECTURER OF ANESTHESIA AND SURGICAL ICU

Tanta University

研究点 (1)

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