| CTRI Number |
CTRI/2026/04/109438 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare two drugs used to blunt the hemodynamic response to laryngoscopy and intubation to determine which is better |
|
Scientific Title of Study
|
A prospective comparative randomised study to evaluate the effectiveness of oral clonidine vs oral pregabalin in attenuating the hemodynamic pressor response during laryngoscopy and tracheal intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil Hospital |
| Address |
Second floor, A Block Department of Anaesthesia D Y Patil Hospital Ayyappa temple Rd, Dr D Y Patil Vidyanagar, Sector 5 Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjulasarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil Hospital |
| Address |
Second floor, A Block Department of Anaesthesia D Y Patil Hospital Ayyappa temple Rd, Dr D Y Patil Vidyanagar, Sector 5 Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjulasarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asmita Shrivastava |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil Hospital |
| Address |
Second floor, A Block Department of Anaesthesia D Y Patil Hospital Ayyappa temple Rd, Dr D Y Patil Vidyanagar, Sector 5 Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8319802138 |
| Fax |
|
| Email |
asmitashrivastava001@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Hospital, Navi Mumbai, Maharashtra, India - 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil Hospital |
| Address |
Second floor, A Block Department of Anaesthesia D Y Patil Hospital Ayyappa temple Rd, Dr D Y Patil Vidyanagar, Sector 5 Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Asmita Shrivastava |
D Y Patil Hospital |
Second floor, A Block Department of Anaesthesia D Y Patil Hospital Ayyappa temple Rd, Dr D Y Patil Vidyanagar, Sector 5 Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA |
8319802138
asmitashrivastava001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research, D. Y. Patil Deemed to be University School of Medicine, Navi Mumbai |
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 |
Clonidine |
Clonidine will be given 120 minutes prior to surgery. Heart rate, Systolic blood pressure, diastolic blood pressure, mean arterial pressure will be noted at time intervals - baseline, 30 minutes after giving drug, Pre-intubation, Post-intubation at 1 minute, 5 minute,10 minutes, 15 minutes, 30 minutes |
| Comparator Agent |
Pregabalin |
Pregabalin will be given 120 minutes prior to surgery. Heart rate, Systolic blood pressure, diastolic blood pressure, mean arterial pressure will be noted at time intervals - baseline, 30 minutes after giving drug, Pre-intubation, Post-intubation at 1 minute, 5 minute,10 minutes, 15 minutes, 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade I, II.
Anticipated duration of surgery between 2-4 hours.
Patient consenting for the trial drug
|
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult intubation.
Patients with High risk of aspirations.
History of Neurologic or seizure disorder.
Hypersensitivity to the drugs.
Patients on beta blockers.
Emergency surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the effect of oral Clonidine and oral Pregabalin in attenuating the hemodynamic pressor response during laryngoscopy and tracheal intubation. |
Baseline, 30 minutes after giving drug, Pre-intubation, Post-intubation at 1 minute, 5 minute,10 minutes, 15 minutes, 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effects |
30 minutes after giving drug, Pre-intubation, Post-intubation at 1 minute, 5 minute,10 minutes, 15 minutes, 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/05/2026 |
| 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="2"
Months="0"
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
|
Study drugs will be given 120 minutes prior to operation then Routine General Anaesthesia will be given, the hemodynamic pressor response to laryngoscopy and tracheal intubation is common and technique to reduce this response by drugs is a routine practice, study will compare two drugs Clonidine and pregabalin used for attenuation of hemodynamic response during laryngoscopy and tracheal intubation. |