| CTRI Number |
CTRI/2024/05/067424 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Preadministration of 6 percent Hydroxy ethyl starch before induction with propofol for reduction of pain on propofol injection. |
|
Scientific Title of Study
|
A prospective interventional study to find out the effect of pre administration of 6 percent Hydroxyethyl starch for reduction of pain on propofol injection in patients undergoing general anaesthesia in Department of Anaesthesia SMS Medical College jaipur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Hospital ,Jaipur |
| Address |
Department of Anesthesiology, Second Floor, Dhanwantari Building, SMS Medical College and Attached Hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Department of Anesthesiology, Second Floor, Dhanwantari Building, SMS Medical College and Attached Hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Sharma |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and Hospital Jaipur |
| Address |
Department of Anesthesiology SMS Medical College and Attached Hospitals Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7733019098 |
| Fax |
|
| Email |
dr.mamtasharma18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology SMS Medical College and Attached Hospitals Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology SMS medical college jaipur |
| Address |
2nd floor Dhanwantari building SMS hospital and attached medical college jaipur. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mamta Sharma |
SMS medical college and attached hospitals. |
Department of anaesthesiology, Operation theatre number 2 ,2nd floor dhanwantari building,SMS hospital jaipur.
Jaipur
RAJASTHAN |
7733019098
dr.mamtasharma18@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% propofol premixed with 2% lignocaine |
Before induction with propofol with 2% lignocaine patients will not given 100 ml of 6% hydroxy ethyl starch unlike intervention group |
| Intervention |
6% Hydroxy ethyl Starch before 1% propofol with 2% lignocaine |
Pre-administration of 100 ml of 6% hydroxy ethyl starch and observe its effect on reduction of pain on propofol 2mg/kg iv injection with 2% lignocaine iv |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia. Patients willing to give written informed consent. ASA grade 1 and 2. |
|
| ExclusionCriteria |
| Details |
Patients with history of allergy to propofol or hydroxy ethyl starch Patients with pre-existing renal or hepatic dysfunction. Patients with cardiovascular disease,hypertension,diabetes. Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of pain on propofol injection between the study groups |
0 second 10 second. 20 second. before loss of verbal contact |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of pain on propofol injection between the study groups |
0 second. 10 second. 20 second. before loss of verbal contact |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
28/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Propofol is most widely used intravenous agent for induction of anaesthesia. The immediate pain is due to irritation of vein and delayed pain is due to kin in release on propofol injection. Colloids have the capacity to modify endothelial cell junctions and permeability of the vascular endothelium by various substances and molecules.With this background we plan to conduct this study to compare the effect of pre-administration of 6% hydroxy ethyl starch for reduction of pain on propofol injection. |