PRE-ADMINISTRATION OF 50ML AND 100ML 6% HYDROXYETHYL STARCH FOR REDUCTION OF PAIN ON PROPOFOL INJECTION

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/03/050378
• Lead Sponsor: Antony Xavier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-03
• Study Start: 2023-06-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain on propofol injection	Outcome will be assessed at the point of administration of propofol. Data will be then assessed at the end of one year.

Trial Locations

Locations (1)

Regional Institute of Medical Sciences, Imphal West, Manipur; 🇮🇳 West, MANIPUR, India

Regional Institute of Medical Sciences, Imphal West, Manipur

🇮🇳West, MANIPUR, India

Antony Xavier

Principal investigator

9037108341

antonyxavier1994@gmail.com