| CTRI Number |
CTRI/2025/06/088662 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
DEXMEDETOMIDINE and LIGNOCAINE
In controlling blood pressure and heart rate during intubation |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind Comparative Study of the Hemodynamic Response to Intravenous Dexmedetomidine Versus Lignocaine During Endotracheal 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 |
Dr Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLNMC AJMER |
| Address |
Jawahar lal nehru medical college,AJMER
Department of Anaesthesia
1st floor
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLNMC AJMER |
| Address |
Jawahar lal nehru medical college,AJMER
Department of anaesthesia , new ot
1st floor
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Mathur |
| Designation |
HOD and Senior Professor |
| Affiliation |
JLNMC AJMER |
| Address |
Jawahar lal nehru medical college,and hospital
Department of anaesthesia
New ot ,1st floor
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, jln medical college ajmer,Rajasthan ,India 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
Jawahar Lal Nehru medical college
ajmer rajashthan
Department of anaesthesia
New ot
305001 |
| 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 Shilpi khandelwal |
JLN medical college |
Department of anaesthesiology New ot 1st floor JLN Hospital ajmer Rajashthan
Ajmer
RAJASTHAN |
07852074789
shilpikhandelwal97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee ,JLN medical college |
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 |
A prospective study if intravenous lignocaine during endotracheal intubation |
30 patients lignocaine 1.5mg/kg in20 ml of 0.9% saline infusion over 3 minutes before induction |
| Comparator Agent |
A prospective study of haemodynamic response of intravenous dexmedetomidine during endotracheal intubation |
30 patients taken and 1gm/kg in 20ml of 0.9% salines fusion over10 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II, age 18-55 yrs |
|
| ExclusionCriteria |
| Details |
Patients sensitive or allergic to drug,obese patient and with predicted difficult airway, and not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic changes during laryngoscope and endotracheal intubation with intravenous dexmedetomidine versus lignocaine from baseline |
To compare the haemodynamic changes during laryngoscope and endotracheal intubation with intravenous dexmedetomidine versus lignocaine from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effect of dexmedetomidine & lignocaine such as hypotension, bradycardia, respiratory depression from baseline |
Any adverse effect of dexmedetomidine & lignocaine such as hypotension, bradycardia, respiratory depression
from baseline |
|
|
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)
|
01/07/2025 |
| 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="1"
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
|
This thesis investigates and compares the effectiveness of two drugs—dexmedetomidine and lignocaine—in controlling the hemodynamic (heart rate and blood pressure) responses caused by endotracheal intubation, a common procedure during general anesthesia. Endotracheal intubation can lead to a significant stress response, which may be harmful in certain patients. The study involved administering either dexmedetomidine or lignocaine intravenously to patients before intubation and monitoring their cardiovascular responses. The findings suggest which of the two drugs is more effective in blunting the rise in heart rate and blood pressure, offering safer anesthesia management during surgery. |