| CTRI Number |
CTRI/2026/04/107384 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| 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
|
Comparison of two methods of giving dexmedetomidine to control blood pressure and heart rate during insertion of a breathing tube in controlled hypertensive patients |
|
Scientific Title of Study
|
Comparing Intravenous Versus Nebulised Dexmedetomidine For
Attenuating Hemodynamic Response To Laryngoscopy And Intubation In
Controlled Hypertensive Patients |
| 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 NAGARAJ |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi. |
| Address |
Department Of Anaesthesiology, Operation Theatre and
Post-Op Room, Main
OT Complex, 2nd
Floor, Dr BSA Hospital
Building, Sector 6,
Rohini, Delhi
North West
DELHI
110085
India |
| Phone |
9071911808 |
| Fax |
|
| Email |
nagarajcmanthale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NEETU CHAUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi. |
| Address |
Department of Anaesthesiology
Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi.
North West
DELHI
110085
India |
| Phone |
7290095547 |
| Fax |
|
| Email |
dr.neetu.hrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NEETU CHAUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi. |
| Address |
Department of Anaesthesiology
Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi.
North West
DELHI
110085
India |
| Phone |
7290095547 |
| Fax |
|
| Email |
dr.neetu.hrc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector-6, Rohini, Delhi. |
|
|
Primary Sponsor
|
| Name |
Dr NAGARAJ |
| Address |
Department Of Anaesthesiology, Dr. Baba Saheb Ambedkar Hospital and Medical college, Sector- 6,
Rohini, Delhi - 110085 |
| 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 |
| Dr NAGARAJ |
Dr. Baba Saheb Ambedkar Hospital, Sector 6, Rohini, Delhi 110085 |
Department Of Anaesthesiology, Operation Theatre and
Post-Op Room, Main
OT Complex, 2nd
Floor, Hospital
Building
North West
DELHI |
9071911808
nagarajcmanthale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, ROHINI, DELHI |
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 |
Intravenous dexmedetomidine |
Dexmedetomidine 1 microgram per kg diluted in 50 ml normal saline, 20 min prior to induction,infused over 10 min |
| Comparator Agent |
Nebulized dexmedetomidine |
Dexmedetomidine 1 microgram per kg diluted in 4 ml normal saline, nebulized over 5
minutes, 15 before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 65 years of either gender with controlled hypertension
2.American Society Of Anaesthesiologists (ASA) physical status II patients
3.Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patient on beta blockers
2.Patients with Cardiac conduction abnormalities 3.Patients with severe hepatic, renal or respiratory dysfunction
4.Pregnant or lactating women
5.Patients with BMI more than 35 kg per meter square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in hemodynamic response specifically heart rate, systolic blood pressure, diastolic blood pressure and
mean arterial pressure during laryngoscopy and endotracheal intubation. |
Baseline, after drug administration and post intubation at 1,3,5,7 and 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events such as bradycardia and hypotension and assessment of sedation levels using Ramsay Sedation Scale |
From drug administration until 10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/04/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Nebulized dexmedetomidine has emerged as a novel non-invasive route of administration. Preliminary studies suggest that nebulized dexmedetomidine is effective in premedication, sedation, and even attenuation of airway reflexes, however limited data are available comparing its efficacy with intravenous administration specifically in controlled hypertensive patients during intubation. Furthermore, most existing literature has focused on normotensive or mixed populations, with a lack of targeted studies in controlled hypertensives, who represent a unique and high-risk subset requiring careful anaesthetic planning. Therefore this study is being done to compare the efficacy of intravenous versus nebulised dexmedetomidine for attenuating hemodynamic response to laryngoscopy and endotracheal intubation in controlled hypertensive patient undergoing elective surgery under general anaesthesia
Study Area Department of Anaesthesiology, Dr. Babasaheb Ambedkar Hospital and Medical College, sector 6, Rohini, Delhi
Primary Objectives To compare intravenous versus nebulised dexmedetomidine groups regarding change in Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure
Secondary Objectives To compare intravenous versus nebulised dexmedetomidine groups regarding Sedation levels using Ramsay Sedation score and adverse events such as bradycardia and hypotension
|