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临床试验/CTRI/2023/06/053406
CTRI/2023/06/053406尚未招募不适用

To evaluate add on effect of hydroxyethyl starch with lignocaine for pain relief following propofol administration

Dayanand Medical College and Hopsital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2023年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
206
试验地点
1
主要终点
Incidence of pain on propofol injection

研究概览

简要总结

Propofol is the most widely used intravenous induction agent in anaesthesia. Pain on propofol injection is a common problem.Even with multimodal techniques,pain on propofol injection is not abolished completely. Hydroxyethyl Starch(HES),a colloid,is a clinically safe and well tolerated complex polysaccharide and has the capacity to modify endothelial cell junctions and permeablity of the vascular endothelium.Pre administration of HES may prevent contact activation of propofol which may in turn lead to reduced pain during propofol injection.A prospective,double blind,randomized study will be conducted on a total of 206 ASA I and II patients of age 18-65 yrs undergoing elective surgery under general anaesthesia who will be randomly allocated into group ’H’ and ’S’ of 103 each. Patients in group ’H’ will be administered 50 ml of 6% HES with 2% lignocaine(1mg/kg) while patients in group ’S’ will be administerd equal volume of 0.9% saline with 2% lignocaine 2mins before induction with 1% propofol(2mg/kg).The incidence and severity of pain on propofol injection will be calculated using Numerical Pain Rating Scale every 15 secs till loss of verbal command. Our aim of the study is to compare the incidence and severity of pain on propofol injetion pre administered with 6%HES with 2% lignocaine or 0.9% saline with 2% lignocaine during induction of anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of American Society of Anaesthesiologists(ASA) physical status I and II 18-65 yrs old either gender undergoing elective surgery under general anaesthesia.

排除标准

  • Emergency surgeries or hemodynamically unstable patients Patients in whom hand or forearm veins will not be accessible Uncontrolled hypertensives and diabetic patients Patients with history of dyspnoea or NYHA III or IV Patients with elevated serum creatinine Patient refusal Known history of allergy to propofol or Hydroxyethyl starch.

结局指标

主要结局

Incidence of pain on propofol injection

时间窗: During induction with propofol-pain score wil be assessed every 15 secs till loss of verbal command

次要结局

  • Severity of pain on propofol injection using numerical rating scale(During induction with propofol-pain score wil be assessed every 15 secs till loss of verbal command)

研究者

发起方
Dayanand Medical College and Hopsital
申办方类型
Private medical college

研究点 (1)

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