| CTRI Number |
CTRI/2025/07/091864 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Doses of Nebulized Dexmedetomidine to Control Blood Pressure and Heart Rate During Intubation |
|
Scientific Title of Study
|
A comparative study of two different doses of nebulized dexmedetomidine for attenuation of hemodynamic responses to laryngoscopy and 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 Anurag Singh |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department Of Anaesthesia ,
Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9839447041 |
| Fax |
|
| Email |
anurag.singh872@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwadeep Singh |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department Of Anaesthesia
Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9927770078 |
| Fax |
|
| Email |
vishwadeepvishen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwadeep Singh |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department Of Anaesthesia
Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9927770078 |
| Fax |
|
| Email |
vishwadeepvishen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ram Murti Smarak Institute of Medical sciences, Bhojipura, Bareilly, Uttar Pradesh-243202 |
|
|
Primary Sponsor
|
| Name |
SRMS IMS |
| Address |
Ram Murti Puram, 13 KM, Bareilly - Nainital Rd, Bhoji Pura, Abheypur Keshonpur, Uttar Pradesh 243202 |
| Type of Sponsor |
Private 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 Anurag Singh |
Shri Ram Murti Smarak Institute of Medical Sciences |
OT Complex, Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences
Bareilly
UTTAR PRADESH |
9839447041
anurag.singh872@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ELECTIVE SURGIERIES FOR ASA GRADE I & II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhaled Dexmedetomidine (1 mcg/kg) |
32 subjects will be administered. Dexmedetomidine nebulization at 1 mcg dose diluted in saline to make a total of 5 ml Group B: 32 subjects will be |
| Comparator Agent |
Inhaled Dexmedetomidine (2mcg/kg) |
32 subjects will be administered. Dexmedetomidine nebulization at 2 mcg dose diluted in saline to make a total of 5 ml
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years of either sex
ASA physical status I/II |
|
| ExclusionCriteria |
| Details |
ASA Grade 3 and 4
Unwillingness to be a part of the trial or patient refusal
Allergy to the study drugs
Uncontrolled comorbidities [Diabetes mellitus, Hypertension, obese,
neurovascular surgeries] and systemic illnesses involving cardiovascular,
nervous or respiratory system, any renal or liver disease
Hemodynamically unstable patient
Pregnancy
Anticipated difficult airway / more than 1 attempt / more than 15 seconds
for intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of nebulized dexmedetomidine [1 mcg / kg] on
hemodynamic responses and on stress response to laryngoscopy and
intubation.
To evaluate the efficacy of nebulized dexmedetomidine [2 mcg / kg] on
hemodynamic and on stress response to laryngoscopy and intubation. |
Hemodynamic parameters HR, SBP, DBP, MAP will be recorded at
baseline than after 5 min and 10 min after inhaling nebulization and at
immediately post induction, and subsequently at 1 min interval for 1st 10
minutes following laryngoscopy and intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of nebulized dexmedetomidine [1 mcg / kg vs 2
mcg / kg] on hemodynamics and myocardial oxygen demand.
To observe adverse effects/ events if any. |
Hemodynamic parameters HR, SBP, DBP, MAP will be recorded at
baseline than after 5 min and 10 min after inhaling nebulization and at
immediately post induction, and subsequently at 1 min interval for 1st 10
minutes following laryngoscopy and intubation. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/08/2027 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To compare the effect of two different doses of nebulized dexmedetomidine in attenuating the hemodynamic and stress responses to laryngoscopy and intubation in patients undergoing elective surgical procedures under general anaesthesia |