| CTRI Number |
CTRI/2025/10/096337 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare oral pregabalin and intravenous dexmedetomidine in decreasing blood pressure and heart rate after laryngoscopy and intubation. |
|
Scientific Title of Study
|
Comparison of oral pregabalin and intravenous dexmedetomidine in attenuating hemodynamic response to laryngoscopy and intubation : A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHUBHADA BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMS, ROHTAK, HARYANA |
| Address |
DEPT. OF ANAESTHESIA, PGIMS ROHTAK, HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9540927325 |
| Fax |
|
| Email |
shubhadabhagat56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHUBHADA BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMS, ROHTAK, HARYANA |
| Address |
DEPT. OF ANAESTHESIA, PGIMS ROHTAK, HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9540927325 |
| Fax |
|
| Email |
shubhadabhagat56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHUBHADA BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMS, ROHTAK, HARYANA |
| Address |
DEPT. OF ANAESTHESIA, PGIMS ROHTAK, HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9540927325 |
| Fax |
|
| Email |
shubhadabhagat56@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SHUBHADA BHAGAT |
| Address |
DEPARTMENT OF ANAESTHESIA, PGIMS, ROHTAK |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SHUBHADA BHAGAT |
PGIMS, ROHTAK |
DEPARTMENT OF ANAESTHESIA, PGIMS, ROHTAK, HARYANA
Rohtak
HARYANA |
9540927325
shubhadabhagat56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BIOMEDICAL RESEARCH ETHICS COMMITTEE PT. B.D. SHARMA PGIMS/UHS,ROHTAK |
Approved |
| Biomedical Research Ethics committee, Pt B.D Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
iv dexmedetomedine |
Group D patients will receive iv dexmedetomidine 1mcg/kg over 10 min.Patients will be preoxygenatated and standard anaesthesia protocol will be followed after this. Hemodynamic response to laryngoscopy and intubation will be assessed at 1, 3, 5, 10 min. |
| Intervention |
oral pregabalin |
Group P patients will receive oral pregabalin 150 mg 1 hour prior to surgery.Patients will be preoxygenatated and standard anaesthesia protocol will be followed after this. Hemodynamic response to laryngoscopy and intubation will be assessed at 1, 3, 5, 10 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 scheduled for elective surgery under general anaesthesia requiring orotracheal intubation |
|
| ExclusionCriteria |
| Details |
Following patients will be excluded from the study
1 Refusal to consent
2 Anticipated difficult airway
3 Patients whose intubation procedure will last more than 15 seconds.
4 Patients with known allergy to study drugs
5 Patients requiring more than 1 intubation attempt
6 Neurosurgery patients
7 Cervical spine instability
8 Patients having history of cardiac or liver disease
9 Patients having baseline heart rate less than 50 in min or having AV blocks
10 Morbid obesity
11 Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether a statistically significant reduction in hemodynamic response to laryngoscopy and intubation occurs with 150 mg oral pregabalin as compared to 1 mcg/kg of iv dexmedetomidine. |
HR, SBP, MAP, DBP at 1 min, 3 min, 5 min and 10 min post intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects like bradycardia, hypotension in intraoperative and postoperative period. Sedation, nausea, vomiting will be noted in postoperative period.
|
Intraoperative and postoperative period for 2 hours |
|
|
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)
|
01/11/2025 |
| 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="4"
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 is a prospective, randomised, double blind, single centre study which aims to compare the efficacy of oral pregabalin and intravenous dexmedetomidine for attenuating the hemodynamic response to laryngoscopy and intubation in patients scheduled for elective surgery under general anaesthesia. A total of 60 patients will be recruited, 30 in each group. HR, SBP, DBP and MAP will be noted at 1 min, 3 min, 5 min and 10 min postintubation. Side effects if any will be noted. Data will be compiled and appropriate statistical tests will be used to compile the results. |