| CTRI Number |
CTRI/2025/07/091518 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study efficacy of two drugs, labetalol and lignocaine in attenuating heart rate and BP in hypertensive patinets while laryngoscopy and intubation |
|
Scientific Title of Study
|
COMPARING THE ATTENUATION OF HEMODYNAMIC RESPONSE WITH
I.V LABETALOL VS I.V LIGNOGAINE IN HYPERTENSIVE PATIENTS DURING LARYNGOSCOPY AND 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 Januba S Subair |
| Designation |
PG Student |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9633463621 |
| Fax |
|
| Email |
janubasubairpottayil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Thamarai Selvi |
| Designation |
Professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thamarai@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR THAMARAI SELVI |
| Designation |
Professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thamarai@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
DR Januba S Subair |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Januba S Subair |
Sri Ramachandra Institute of higher education and research |
A6, Department of Anaesthesiology, Sri Ramachandra Institute of higher education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU |
9633463621
janubasubairpottayil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IV LABETALOL |
The patients receive Intravenousl injection Labetalol in a dose of 0.25mg/kg given 5 minutes prior to intubation. Postintubation hemodynamic responses are noted at 1,3,5, 10 minutes after
intubation |
| Intervention |
IV Lignocaine |
The patients receive intravenous injection of 2%
Lignocaine hydrochloride(without preservative) in a
dose of 1.5 mg/kg before 90 seconds of
laryngoscopy and intubation and post intubation hemodynamic responses are noted at 1,3,5, 10 minutes after
intubation |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All hypertensive patients between age of 24-80
ASA II |
|
| ExclusionCriteria |
| Details |
H/o chest pain/syncope/palpitations, any respiratory illness or he;antic or renal issues
ASA III or more
Pregnant and lactating women
Morbid obesity
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of 2different drugs in
attenuating the hemodynamic response to
laryngoscopy and intubation |
1, 3, 5, 7 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IV LABETALOL is better in attenuating hemodynamic responses when compared to IVLIGNOCAINE |
1, 3, 5, 7 minutes |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
04/08/2025 |
| 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
|
The hemodynamic changes during intubation can accelerate the development of myocardial ischemia/arrhythmia/infarction and cerebral haemorrhage The rise in blood pressure is due to increase in cardiac output rather than an increase in systemic vascular resistance, and is associated with the transient rise in central venous pressure.The aim of the study is to compare the efficacy of 2 different drugs for controlling these hemodynamic responses under Anesthestic techniques. |