| CTRI Number |
CTRI/2024/07/071287 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| 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
|
A randomized study to compare the effect of low-dose Ketamine versus Fentanyl on the hemodynamic response to laryngoscopy and endotracheal intubation. |
|
Scientific Title of Study
|
A randomized study to compare the effect of low-dose Ketamine versus Fentanyl on the hemodynamic response to laryngoscopy and endotracheal intubation in Department of Anaesthesiology, SMS Medical College and Attached Hospitals, 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 |
Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantari building, SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, second floor, Dhanwantari building, SMS Medical College
RAJASTHAN
302019
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ambili TP |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
8939271261 |
| Fax |
|
| Email |
tpambili95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, S.M.S Medical College and Attached Hospitals , Jaipur, Rajasthan, India. Pincode: 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College |
| Address |
Department of Anaesthesiology , SMS Medical College,JLN Marg, Adarsh Nagar, JAIPUR |
| 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 Ambili TP |
SMS Medical college |
Operation Theatre, Department of Anaesthesiology, SMS Medical College, JLN Marg, Adarsh Nagar
Jaipur
RAJASTHAN |
8939271261
tpambili95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics committee, SMS Medical College and attached hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
1 microgram/kg Fentanyl intravenously giving only once before 3 minutes of induction of anaesthesia |
| Intervention |
Ketamine |
0.5 mg/kg Ketamine intravenously giving only once before 3 minutes of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Elective Surgery under General Anaesthesia
Patient willing to give informed and written consent
Age group between 18-50
ASA grade 1&2 |
|
| ExclusionCriteria |
| Details |
1. History of allergy or contraindications of any study drug
2. Patients scheduled for emergency surgery
3. Hypertension - known or previously dignosed
4. Pregnancy
5. Dementia or psychiatric illness
6. Known Ischemic heart disease
7. Raised intracranial pressure or intracranial pathology where a rise in intracranial pressure would pose a risk or patients scheduled for neurosurgical procedures
8. History or indicator of or proven difficult ventilation or laryngoscopy or intubation
Intubation time more than 30 seconds or repeated attempts at intubation 9 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hypertension |
At baseline when patient comes to Operation theatre, post induction- within 1 minute of giving induction agent, during laryngoscopy, just after intubation and at 2, 4, 6, 8,10 minutes interval after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tachycardia , post induction hypotension & any side effects |
At baseline, post induction, during laryngoscopy, just after intubation & for 10 minutes at 2 minutes interval |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="3"
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
|
This study is a randomised double blinded comparative study between Low dose Ketamine (0.5mg/kg) and Fentanyl in attenuating hemodynamic response to laryngoscopy and endotracheal intubation in 66 patients undergoing surgeries under General Anaesthesia. The primary outcomes are systemic blood pressure, diastolic blood pressure, mean arterial pressure, and mean heart rate at different time points like before laryngoscopy, during induction, during laryngoscopy and after laryngoscopy at 2 minutes intervals for 10 minutes and nothing side effects if any. |