| CTRI Number |
CTRI/2024/10/074696 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of pretreatment with lignocaine, dexmeditomidine or ketamine in providing relief from Propofol injection pain and withdrawal movements during induction of anaesthesia |
|
Scientific Title of Study
|
Comparative study of pretreatment with Lignocaine, Dexmeditomidine or Ketamine in providing relief from Propofol injection pain and withdrawal movements during induction of 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 |
Shivangi Sharma |
| Designation |
Post Graduate resident |
| Affiliation |
Shri Bhausaheb Hire government medical college |
| Address |
Department of Anaesthesiology and critical care, Shri Bhausaheb Hire government medical college, Chakkarbardi, Mumbai-Agra highway, Samta nagar Dhule Maharashtra-424001
103-D Platinum Enclave DDA SFS Flats Pocket-I Sector -18 Rohini New Delhi-110089
Dhule
MAHARASHTRA
424001
India |
| Phone |
9810390606 |
| Fax |
|
| Email |
shivangibps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandip Thorat |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire government medical college |
| Address |
Department of Anaesthesiology & Critical care
Shri Bhausaheb Hire government medical college, Chakkarbardi, Mumbai-Agra highway, Samta nagar Dhule Maharashtra
Dhule
MAHARASHTRA
424001
India |
| Phone |
9822542870 |
| Fax |
|
| Email |
drsandipthorat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandip Thorat |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire government medical college |
| Address |
Department of Anaesthesiology & Critical Care
Shri Bhausaheb Hire government medical college, Chakkarbardi, Mumbai-Agra highway, Smta nagar Dhule Maharashtra
MAHARASHTRA
424001
India |
| Phone |
9822542870 |
| Fax |
|
| Email |
drsandipthorat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology & Critical care Shri Bhausaheb Hire government medical college and hospital, Chakkarbardi, Mumbai-Agra highway Samta nagar Dhule Maharashtra-424001 India |
|
|
Primary Sponsor
|
| Name |
Shivangi Sharma |
| Address |
Department of Aneasthesiology & Critical care
Sri Bhausaheb Hire government medical college, Chakkarbardi Mumbai-Agra highway Samta nagar Dhule Maharashtra-424001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Bhauseheb Hire government medical college |
Chakkarbardi, Mumbai- Agra highway, Samta nagar Dhule, Maharashtra- 424001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivangi Sharma |
Shri Bhausaheb Hire government medical college and hospital |
Shri Bhausaheb Hire government medical college and hospital, Chakkarbardi, Mumbai-Agra highway Samta nagar Dhule Maharashtra-424001
Dhule
MAHARASHTRA |
9810390606
shivangibps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SBHGMC Dhule |
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 |
Dexmeditomidine |
0.5 microgram/kg body weight Dexmeditomidine diluted unto 5 ml using normal saline, intravenous, 10 minute before Propofol injection |
| Intervention |
Ketamine |
0.2mg/kg body weight diluted unto 5ml using normal saline, intravenous, 1 minute before Propofol injection |
| Intervention |
Lignocaine |
2ml(40mg) of 2 % Lignocaine (preservative free) diluted unto 5ml using normal saline, intravenous, 1 minute before Propofol injection |
| Comparator Agent |
Propofol |
Propofol 2mg/kg body weight, intravenous at induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients from 18-65 years undergoing elective surgical procedures under general anaesthesia using endotracheal intubation
2.American Society of Anaesthesiologist grade I and II
3. Body mass index less than 30kg/metre square |
|
| ExclusionCriteria |
| Details |
1. History of pulmonary, renal, hepatic, endocrine, neurological disease
2. Patients with cardiovascular diseases including hypertension on beta blockers, digitalis etc
3. Pregnant and lactating females
4. Patients on any sedatives or analgesics
5. Emergency surgical procedures
6.History of drug abuse or psychiatric illness
7. Hypersensitivity to study drugs
8. Subjects with anticipated difficulty in venous access |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of pain alleviation and withdrawal movements due to propofol injection during induction of anaesthesia |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
6 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
03/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is a randomized, triple blinded and parallel group clinical trial comparing the efficacy of pretreatment with Lignocaine, Dexmeditomidine and Ketamine in providing relief from propofol injection pain and withdrawal movements during induction of aneasthesia for a period of 1 year in 96 patients.. It will be conducted at a tertiary care hospital in India. The primary outcome measures degree of pain alleviation and withdrawal movements due to Propofol injection during induction of anaesthesia using Lignocaine, Dexmeditomidine or Ketamine as pre treatment. The secondary outcome measures variations in hemodynamic parameters. |