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
|
|
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
|
|
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. |