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临床试验/CTRI/2023/03/050378
CTRI/2023/03/050378尚未招募不适用

Effect of pre-administration of 50ml and 100ml 6% hydroxyethyl starch for reduction of pain on propofol injection: A Randomized Controlled Study

Antony Xavier1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年6月3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
180
试验地点
1
主要终点
Pain on propofol injection

研究概览

简要总结

Propofol (2,6-di-isopropyl phenol), has become themost popular intravenous anesthetic drug for induction, maintenance ofanesthesia, and sedation. However, pain on propofol injection is aproblem. The incidence of pain following propofol injection varies between28-90% in adults if a vein on the dorsum of the hand is used. Varioustechniques to mitigate this pain include administration in larger vein,pre-mixing with lignocaine, pre-administration of sub-anesthetic doses ofketamine, using a mixture of medium and long-chain triglycerides in the carrieremulsion, etc. However, even with multimodal techniques, pain on propofolinjection is not abolished completely. It has been shown thatpre-administration of colloid prevents contact activation by propofol, whichmay lead to reduced pain during injection. With this background and in search for the ideal dose,we will be conducting a study to compare the effects of pre-administration of50ml and 100ml 6% Hydroxy Ethyl Starch (HES) in attenuation of propofolinjection pain during induction of anesthesia. This study will be a randomizeddouble blinded, comparative study, to be carried out on 180 patients, of ASA Iand II undergoing elective surgery under general anaesthesia. The patients willbe randomly divided into three groups of 60 each. Group H50 (n=60) will receive50ml hydroxyethyl starch. Group H100 (n=60) will receive 100 ml hydroxyethylstarch. Group S (n=60) will receive 50 ml of normal saline. The pain response will beassessed and recorded using a 4- point Verbal Rating Score. All the findingsand observations made during the entire study will be tabulated, graphicallydepicted wherever possible, statistically analyzed and inference will be drawnto evaluate and compare the effect of pre-administration of 50ml and 100mlhydroxyethyl starch for reduction of pain on propofol injection.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of age group 18 to 60 years.
  • (Dose adjustment of hydroxyethyl starch needed in paediatric and >60 years of age) 2.Patients of American Society of Anaesthesiologists (ASA) physical grade I or II.

排除标准

  • 1.Patients with neurological deficits.
  • 2.Patients with history of allergy 6% hydroxy ethyl starch and propofol.
  • 3.Patients taking any analgesic before surgery.
  • 4.Patients with diabetes, hypertension, cardiac disease, hepatic, renal, pulmonary disease and convulsion.
  • 5.Patients with morbid obesity.
  • 6.Patients with anticipated difficult venous access.
  • 7.Patients with pregnancy and breastfeeding.
  • 8.Patients with chronic pain syndromes.
  • 9.Patients with disorders of lipid metabolism.
  • 10.Patients having problems in communication.

结局指标

主要结局

Pain on propofol injection

时间窗: Outcome will be assessed at the point of administration of propofol. Data will be then assessed at the end of one year.

次要结局

未报告次要终点

研究者

发起方
Antony Xavier
申办方类型
Other [Post Graduate Trainee]

研究点 (1)

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