| CTRI Number |
CTRI/2020/09/027820 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
07/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prevention of pain on injection of drug (propofol) given during general anesthesia using ice gel pack |
|
Scientific Title of Study
|
Prevention of pain on injection of propofol using ice gel packs:a prospective clinical trial(PRICE-I trial) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeev Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of anesthesia and intensive care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
dr.rajeevchauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeev Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of anesthesia and intensive care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
dr.rajeevchauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeev Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER |
| Address |
Department of anesthesia and intensive care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
dr.rajeevchauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia nd intensive care
PGIMER |
|
|
Primary Sponsor
|
| Name |
Rajeev Chauhan |
| Address |
Department of anesthesia nad intensive care, PGIMER,Chandigarh |
| 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 |
| Rajeev Chauhan |
PGIMER |
department of anesthesia and intensive care
Chandigarh
CHANDIGARH |
7087422950
dr.rajeevchauhan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee,PGIMER |
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 |
GEL PACK |
this will be applied proximal to the cannula for 3mins |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65
2.ASA I, II & III
3.Elective Surgeries
4.Undergoing general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1.Not willing to participate
2.Any local site infection
3.Allergy to eggs
4.Rapid Sequence Induction
5.Anticipated difficulty in venous access
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the reduction in the severity of pain after propofol injection due to application of Ice-gel pack causing local cooling |
10 secs after propofol injection (25% of calculated dose) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="360" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2020 |
| Date of Study Completion (India) |
07/11/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
propofol is the commomest intravenous inducing agent for general anesthesia. however 3 out of 5 patients complain of pain on its injection. we want to study the effect of thermotherapy in reducing the pain of propofol injection |