| CTRI Number |
CTRI/2024/07/070369 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
We want to study about Effect of Intravenous Fentanyl Versus Intravenous Fentanyl and Paracetamol on Hemodynamic Response to Laryngoscopy and Endotracheal Intubation in patients undergoing General Surgeries |
|
Scientific Title of Study
|
Effect of Intravenous Fentanyl Versus Intravenous Fentanyl and Paracetamol on Hemodynamic Response to Laryngoscopy and Endotracheal Intubation : A Prospective Randomized Double Blind Interventional Study at SMS Medical College Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2
SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
suncha87@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2
SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
suncha87@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Narang |
| Designation |
Resident Doctor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2
SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9587988651 |
| Fax |
|
| Email |
dpk.rnt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN INDIA -302004 |
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN 302004 |
| 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 |
| Dr Sunil Chauhan |
SMS MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology operation theater 2 Jaipur RAJASTHAN
Jaipur
RAJASTHAN |
9414077324
suncha87@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
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 |
Attenuating the Hemodynamic Response to Laryngoscopy and endotracheal intubation by use of iv fentanyl and IV Normal saline 100 ml up to 10 min after intubation in General Anaesthesia |
| Comparator Agent |
Fentanyl and paracetamol |
Attenuating the Hemodynamic response to Laryngoscopy and Endotracheal intubation by use of iv fentanyl and Iv paracetamol 15mg/kg (100 ml) up to 10 min after intubation under general Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent.
Patient posted for elective surgeries under General anaesthesia
ASA physical status classification 1 & 2
|
|
| ExclusionCriteria |
| Details |
Patients with predictive difficult intubation such as short neck
Patient with mallampatti class III AND IV
Weight more than 90 kg
Pregnant women
Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Systolic Blood Pressure
Mean Diastolic Blood pressure
Mean of Mean arterial pressure
Mean Heart Rate |
1 min , 2 min , 4 min , 6 min , 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in percentage in cases who develop side effect in both group |
Up to 12 hours of extubation |
|
|
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)
|
01/08/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The hemodynamic response to laryngoscopy and tracheal intubation in most patients are transient, highly variable, and probably of little consequences but may have adverse effects like arrhythmias, myocardial ischemia, left ventricular failure, increased intracranial pressure, and rupture of cerebral aneurysm on patients with pre-existing cardiovascular disease and cerebrovascular disease. In this study we will compare the effectiveness of intravenous fentanyl versus a combination of intravenous fentanyl and paracetamol on hemodynamic responses to laryngoscopy and endotracheal intubation under general anaesthesia
|