| CTRI Number |
CTRI/2022/09/045366 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
03/09/2022 |
| 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
|
“COMPARISON OF PROPOFOL AND ETOMIDATE -TWO INTRAVENOUS ANAESTHETIC AGENTS TO ASSESS STRESS RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION†|
|
Scientific Title of Study
|
“COMPARISON OF PROPOFOL VS ETOMIDATE AS AN INDUCTION AGENT TO EVALUATE HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YOGESH PALIWAL |
| Designation |
POSTGRADUATE RESIDENT IN ANAESTHESIOLOGY |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL, AHMEDABAD |
| Address |
103 KRISHNA NAGAR JATTAL ROAD PANIPAT HARYANA
Panipat
HARYANA
132103
India |
| Phone |
8814071212 |
| Fax |
|
| Email |
dr.yogeshpaliwal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S J GOSWAMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL AHMEDABAD |
| Address |
A-1004 ANMOL TOWER CAMP ROAD SHAHIBAUG AHMEDABAD
Ahmadabad
GUJARAT
380004
India |
| Phone |
9327021192 |
| Fax |
|
| Email |
dhrumit09@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S J GOSWAMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL AHMEDABAD |
| Address |
A-1004 ANMOL TOWER CAMP ROAD SHAHIBAUG AHMEDABAD
Ahmadabad
GUJARAT
380004
India |
| Phone |
9327021192 |
| Fax |
|
| Email |
dhrumit09@yahoo.com |
|
|
Source of Monetary or Material Support
|
| B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL, GOVERNMENT OF GUJARAT |
|
|
Primary Sponsor
|
| Name |
CIVIL HOSPITALGOVERNMENT OF GUJARAT |
| Address |
7TH FLOOR, 7TH BLOCK, HEALTH AND FAMILY WELFARE DEPARTMENT, NEW SACHIVALAY, GANDHINAGAR |
| 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 |
| YOGESH PALIWAL |
GENERAL SURGERY OPERATION THEATERS |
MAJOR SURGERY OPERATION THEATERS
DEPARTMENT 5TH FLOOR, TRAUMA BUILDING
Ahmadabad
GUJARAT |
8814071212
dr.yogeshpaliwal12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL, AHMEDABAD |
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 |
“COMPARISON BETWEEN PROPOFOL 3MG/KG AND ETOMIDATE 0.3MG/KG AS AN INDUCTION AGENT TO EVALUATE HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION†|
"TWO INTRAVENOUS INDUCTION AGENTS PROPOFOL AND ETOMIDATE USED FOR ENDOTRACHEAL INTUBATION AND ITS EFFECTS ON BLOOD PRESSURE, HEART RATE AND SPO2 ARE COMPARED" |
| Comparator Agent |
“USING TWO DIFFERENT INTRAVENOUS INDUCTION DRUGS, PROPOFOL AND ETOMIDATE FOR ENDOTRACHEAL INTUBATION" |
“BOTH DRUGS PROPOFOL 3MG/KG AND ETOMIDATE 0.3MG/KG ARE USED TO EVALUATE HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION†|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2,3 PATIENTS POSTED FOR GENERAL SURGERY FOR SURGERY UNDER GENERAL ANESTHESIA REQUIRING ENDOTRACHEAL INTUBATION |
|
| ExclusionCriteria |
| Details |
Refusal to give consent
Age<12yrs
ASA grade IV - V
Known allergies to anaesthetic drugs
Patients hemodynamically or neurologically unstable
Patient having neurological or psychiatric disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EVALUATION OF PROPOFOL VS ETOMIDATE AS AN INDUCTION AGENT TO HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION. |
FROM THE TIME OF INDUCTION TO 30 MIN POST ENDOTRACHEAL INTUBATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CHANGES IN INTRA-OPERATIVE HEMODYNAMIC CHANGES
ANY COMPLICATIONS LIKE APNEA, MYOCLONUS |
FROM THE TIME OF INDUCTION TO 30 MIN POST ENDOTRACHEAL INTUBATION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/09/2022 |
| 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
|
DESPITE ADEQUATE ANAESTHETIC DEPTH, DIRECT LARYNGOSCOPY AND INTUBATION ELICIT A SIGNIFICANT ADRENO-SYMPATHETIC RESPONSE. THE RESPONSE, AS MANIFESTED BY CHANGE IN BLOOD PRESSURE(BP), HEART RATE(HR), ARRYTHMIAS, etc. THE PRESENT STUDY WAS UNDERTAKEN TO COMPARE PROPOFOL AND ETOMIDATE AS AN INDUCTION AGENT TO EVALUATE HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION. |