| CTRI Number |
CTRI/2020/05/025000 [Registered on: 04/05/2020] Trial Registered Prospectively |
| Last Modified On: |
14/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intravenous colloid infusions for prevention of pain on propofol injection |
|
Scientific Title of Study
|
Effect of 6% hydroxyethyl starch (130/0.4) for prevention of pain on propofol injection: randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Sijua
Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Sijua, Patrapada
Bhubaneswar 751019, Odisha, India |
|
|
Primary Sponsor
|
| Name |
Dr Satyajeet Misra |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Satyajeet Misra |
AIIMS Bhubaneswar |
Room No 409
Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
6 % Hydroxyethyl starch (130/0.4) |
100 ml (bolus), once, i.v, before administration of anesthesia |
| Comparator Agent |
Normal Saline 0.9% |
100 ml (bolus), once, i.v, before administration of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Hypertensives; diabetics; known LV dysfunction; known allergy to Propofol or hydroxyethyl starch |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain on propofol injection |
During administration of propofol while giving anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
2 hours after recovery from anesthesia |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2020 |
| Date of Study Completion (India) |
01/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Indian J Anaesth. 2022 Feb;66(2):107-111. doi: 10.4103/ija.ija_884_21 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Propofol is an excellent induction agent for anaesthesia, However, pain on propofol injection is an unpleasant experience for most patients undergoing surgery. Many agents including local anaesthetics, opioids, antiemetics, hypnotics have all been tried to mitigate the pain on propofol injection with varying degrees of success. Colloids are usually given to patients undergoing surgery to maintain the intravascular volume and adequate tissue perfusion. Preloading with colloids is also a common practice to prevent hypotension during induction of anaesthesia. There is evidence that colloids prevent the adhesion of platelets and other molecules to venous endothelium by coating the veins. Since the main mechanism of pain is irritation of veins due to release of kinins by direct activation of venous endothelium by the phenol moiety of propofol, it would be useful to see if the pre-administration of colloids would coat the venous endothelium and prevent the contact activation of the venous endothelium by propofol and thus, prevent the pain on propofol injection. |