| CTRI Number |
CTRI/2021/08/035362 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
29/07/2021 |
| 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
|
comparing the analgesic effect between a local anaesthetic and a drug used for induction in alleviating the pain caused while administering a lipid emulsion drug during induction of general anaesthesia.
|
|
Scientific Title of Study
|
Comparison between effect of intravenous lignocaine and ketamine in alleviating propofol injection pain in patients undergoing surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J Sivagurunathan |
| Designation |
Post Graduate |
| Affiliation |
Chettinad Hospital and Research Institute kancheepuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8248310015 |
| Fax |
|
| Email |
sivagurunathanj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok Kulasekhar |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute kancheepuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Kulasekhar |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute kancheepuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr J Sivagurunathan
Department of Anaesthesia
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram District
TamilNadu 603103
India |
|
|
Primary Sponsor
|
| Name |
J Sivagurunathan |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai,
Kelambakkam
TamilNadu 603103 |
| Type of Sponsor |
Other [J Sivagurunathan] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Chettinad Academy of Research and Education |
Department of Anaesthesia
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram District
TamilNadu 603103
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| J Sivagurunathan |
Chettinad Hospital and Research Institute |
Department of Anaesthesiology
Chettinad Hospital and Research institute
Kelambakkam
Kancheepuram 603103
Tamilnadu
India
Kancheepuram
TAMIL NADU |
8248310015
sivagurunathanj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
Alleviating propofol injection pain |
Administering 15 mg ketamine or 21.3 mg lignocaine intravenously 30 seconds before propofol injection to reduce propofol injection pain during induction of general anaesthesia |
| Comparator Agent |
Alleviating propofol injection pain with study drug |
Comparing the analgesic effect of intravenous Lignocaine(21.3mg) and Ketamine(15mg) to reduce propofol injection pain during induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2 patients undergoing surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal study
Known allergy for study drug
Pregnant females
Cardiovascular diseases, renal and hepatic dysfunctions
ASA PS 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the incidence of propofol injection pain in patients undergoing surgery under general anaesthesia |
30 seconds after giving study drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the severity of propofol injection pain in patients undergoing surgery under general anaesthesia |
30 seconds after giving study drug |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/08/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to reduce the incidence and severity of propofol injection pain in patients undergoing surgery under general anaesthesia
|