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临床试验/CTRI/2024/01/061670
CTRI/2024/01/061670尚未招募Phase 3 4

Pre-Administration of 6% Hydroxyethyl Starch For Reduction of Pain on Propofol Injection: A Placebo Controlled Randomised Study

JLN medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Pain during propofol injection

研究概览

简要总结

After thorough preoperative assessment of each patient, written informed consent will be taken. on arrival in the operating room, an 18 G cannula is inserted. No analgesic premedication will be given. The study drug HES/ NS will be drawn up in two 50 ml syrings and administer it over three to 5 minutes.once the 100 ml bolus is over, all patients will be premedicated with inj.glycopyrolate 0.004mg/ kg if and inj. Tramadol 2 mg/ kg if.Preoxygenation will be done with 100% O2 for 3 minutes. Induction will be done using inj. Propofol 1.2 to 2.5 mg/kg if administered till loss of verbal contact. During propofol injection pain will be assessed Evert 5 to 10 seconds before the loss of verbal contact as 0- no pain, 1-mild pain,2- moderate and 3 - severe using Mc Crimick and hunter scale, tracheal intubation will be facilitated with inj.succinylscholine 2mg/ kg.Trachea will be intubated. General anaesthesia will be maintained with oxygen , inj atracurium and supplemented with inhalational sevoflurane.Routine ASA monitoring will be established. The vital parameters will be recorded. All patients will be asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as no recall of pain present.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients undergoing elective surgery under general anaesthesia ASA class 1 and 2.

排除标准

  • Patients undergoing emergency surgery Patients in whom hand or forearm veins are not accessible Patients with comorbidites Patient refusal.

结局指标

主要结局

Pain during propofol injection

时间窗: Assessment of pain during propofol injection by Mc Crimick and hunter scale degree of pain during 2,5,10,20 seconds

Post operative pain recall

时间窗: Assessment of pain during propofol injection by Mc Crimick and hunter scale degree of pain during 2,5,10,20 seconds

次要结局

  • Haemodynamic changes(To compare the severity of propofol injection pain)

研究者

发起方
JLN medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr VEENA MATHUR

JLN medical College and hospital

研究点 (1)

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