| CTRI Number |
CTRI/2025/01/078910 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing fentanyl and lignocaine pretreatment effect for prevention of pain caused by propofol injection |
|
Scientific Title of Study
|
Comparison of fentanyl vs lignocaine as pretreatment for prevention of pain on propofol injection in patients undergoing general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehak Grover |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9501613273 |
| Fax |
|
| Email |
mehakgrover19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab 151203 India |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India |
| 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 |
| Mehak Grover |
Guru Gobind Singh Medical College Hospital |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB |
9501613273
mehakgrover19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Guru Gobind Singh Medical College |
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 |
Fentanyl |
Patients will receive intravenous fentanyl 100 µg (2ml) before propofol (5ml) injection.The patients will be observed for incidence of pain, severity of pain using four point pain score, skin reactions, haemodynamic changes and patient satisfaction score. |
| Comparator Agent |
Lignocaine |
Patients will receive intravenous lignocaine 2% 40 mg (2ml) before propofol (5ml) injection.The patients will be observed for incidence of pain, severity of pain using four point pain score, skin reactions, haemodynamic changes and patient satisfaction score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-60 years of either gender, giving valid informed and written consent.
Patients belonging to American Society of Anesthesiology(ASA) grade I, and II.
|
|
| ExclusionCriteria |
| Details |
Participants with a history of allergy to any of the study drugs.
Hemodynamically unstable participants.
Patients taking analgesics before surgery
Participants with difficult venous cannulation with 18G IV cannula satisfactorily in any large peripheral vein of the hand.
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate pain on injection of fentanyl and lignocaine pre-treatment for pain caused by propofol injection using 4 point pain score |
After 10 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study pain, edema, wheal and flare of patients who received fentanyl and lignocaine pre-treatment for pain caused by propofol injection. |
After one hour of induction. |
| To study patient satisfaction score of patients who received fentanyl and lignocaine pre-treatment for pain caused by propofol injection. |
After extubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="6"
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 the most widely used intravenous (IV) anaesthetic agent for induction and maintenance of anaesthesia as well as for sedation inside and outside operation theatre. Propofol is almost an ideal IV anaesthetic agent, but pain on its injection is a problem. Several methods have been used to attenuate the pain. Lignocaine is used routinely. Fentanyl is also an effective alternative.In present study, we propose to evaluate and compare fentanyl100mcg (2ml) vs lignocaine2% 40 mg (2ml)as pre-treatment for attenuation of pain caused by propofol injection.The patients will be observed for incidence of pain, severity of pain using four point pain score, skin reactions, haemodynamic changes and patient satisfaction score. |