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CTRI Number  CTRI/2023/03/050378 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 04/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   PRE-ADMINISTRATION OF 50ML AND 100ML 6% HYDROXYETHYL STARCH FOR REDUCTION OF PAIN ON PROPOFOL INJECTION 
Scientific Title of Study   Effect of pre-administration of 50ml and 100ml 6% hydroxyethyl starch for reduction of pain on propofol injection: A Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
A/206/REB-Comm(SP)/RIMS/2015/826/167/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANTONY XAVIER 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  9037108341  
Fax    
Email  antonyxavier1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rupendra Singh Thokchom 
Designation  Associate Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  9774247043  
Fax    
Email  penbeeru63@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rupendra Singh Thokchom 
Designation  Associate Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  9774247043  
Fax    
Email  penbeeru63@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur 
 
Primary Sponsor  
Name  Antony Xavier 
Address  Regional Institute of Medical Sciences, Imphal, Manipur 
Type of Sponsor  Other [Post Graduate Trainee] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Antony Xavier  Regional Institute of Medical Sciences, Imphal West, Manipur  Elective surgery Operation theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur
Imphal West
MANIPUR 
9037108341

antonyxavier1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  100 ml normal saline  Study participants will be randomized into three groups. Comparator group receiving 100ml Normal saline over ten minutes before administration of propofol during induction of anaesthesia 
Intervention  Pre-administration of 50ml or 100 ml 6% hydroxyethyl starch   Study participants will be randomized into three groups. Intervention group receiving either 50ml 6% hydroxyethyl starch or 100 ml hydroxyethyl starch over ten minutes before administration of propofol during induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Propofol (2,6-di-isopropyl phenol), has become the most popular intravenous anesthetic drug for induction, maintenance of anesthesia, and sedation. However, pain on propofol injection is a problem. The incidence of pain following propofol injection varies between 28-90% in adults if a vein on the dorsum of the hand is used. Various techniques to mitigate this pain include administration in larger vein, pre-mixing with lignocaine, pre-administration of sub-anesthetic doses of ketamine, using a mixture of medium and long-chain triglycerides in the carrier emulsion, etc. However, even with multimodal techniques, pain on propofol injection is not abolished completely. It has been shown that pre-administration of colloid prevents contact activation by propofol, which may 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 of 50ml and 100ml 6% Hydroxy Ethyl Starch (HES) in attenuation of propofol injection pain during induction of anesthesia. This study will be a randomized double blinded, comparative study, to be carried out on 180 patients, of ASA I and II undergoing elective surgery under general anaesthesia. The patients will be randomly divided into three groups of 60 each. Group H50 (n=60) will receive 50ml hydroxyethyl starch. Group H100 (n=60) will receive 100 ml hydroxyethyl starch. Group S (n=60) will receive 50 ml of normal saline. The pain response will be assessed and recorded using a 4- point Verbal Rating Score. All the findings and observations made during the entire study will be tabulated, graphically depicted wherever possible, statistically analyzed and inference will be drawn to evaluate and compare the effect of pre-administration of 50ml and 100ml hydroxyethyl starch for reduction of pain on propofol injection.

 
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