| CTRI Number |
CTRI/2026/01/102624 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Prospective Randomized Study Comparing the Efficacy of Nebulized Dexmedetomidine and Nebulized Magnesium Sulphate in Attenuating the Hemodynamic Response to Laryngoscopy and Tracheal Intubation |
|
Scientific Title of Study
|
A prospective randomised study to compare the efficacy of Nebulized Dexmedetomidine and Nebulized Magnesium Sulphate for Attenuation of Hemodynamic Response during Laryngoscopy and Tracheal 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 |
Rohit Kumar |
| Designation |
Post Graduate |
| Affiliation |
Adesh Medical College and Hospital Mohri Kurukshetra |
| Address |
VPO Nathusari Chopta District Sirsa Haryana
Room no. 1 3rd floor,Department of anesthesia
Kurukshetra
HARYANA
125110
India |
| Phone |
9545378653 |
| Fax |
|
| Email |
happychoudhary08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Wahi |
| Designation |
Professor |
| Affiliation |
Adesh Medical College and Hospital Mohri Kurukshetra |
| Address |
Room no. 4, 3rd Floor, Department of anesthesia, Adesh Medical College and hospital , mohri
Kurukshetra
HARYANA
136134
India |
| Phone |
9530582189 |
| Fax |
|
| Email |
ajaywahi81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Kumar |
| Designation |
Post Graduate |
| Affiliation |
Adesh Medical College and Hospital Mohri Kurukshetra |
| Address |
VPO Nathusari Chopta District Sirsa Haryana
Room no. 1,3rd floor,Department of anesthesia
Kurukshetra
HARYANA
125110
India |
| Phone |
9545378653 |
| Fax |
|
| Email |
happychoudhary08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Adesh Medical College and Hospital |
| Address |
Adesh medical College and hospital NH -44 mohri,kurukhetra Haryana, India PIN code - 136134 |
| 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 Rohit kumar |
Adesh Medical College and Hospital Mohri Kurukshetra |
Room no. 1,3rd floor, Department of anesthesia
Kurukshetra
HARYANA |
09545378653
happychoudhary08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adesh Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Grade 1 and 2 for surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) grade I or II.
2. Age 18–60 years.
3. Elective surgery under general anesthesia requiring laryngoscopy and intubation
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Contraindications to these drugs.
3. History of difficult airway MPS grade 3/4 or failed intubation.
4. Chronic use of sedatives, oral magnesium supplements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of nebulised magnesium sulfate and dexmedetomidine by measuring changes in heart rate , Systolic BP , Diastolic BP and Mean BP during and after laryngoscopy |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To estimate the incidence of postoperative sore throat & other side effects.
2.To assess serum magnesium levels in all the groups
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
10/04/2026 |
| 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="1"
Months="6"
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
|
Research comparing nebulised magnesium sulfate and dexmedetomidine is scarce. Most studies focus on intravenous administration leaving a gap in understanding their relative efficacy and safety when administered through nebulisation. Magnesium sulphate has high therapeutic index and no known interactions with commonly used anti-hypertensive drugs as compared to Dexmedetomidine where bradycardia, hypotension and AV block is encountered. So, this prospective randomized study is planned to compare the efficacy and safety profile of nebulised magnesium sulfate and dexmedetomidine in attenuating the hemodynamic stress response during laryngoscopy and Tracheal intubation in patients undergoing elective surgery under general anesthesia. OBJECTIVE 1.To
compare the effectiveness of nebulised magnesium sulfate and dexmedetomidine by
measuring changes in heart rate , Systolic BP , Diastolic BP and Mean BP during and after laryngoscopy. 2.To estimate the incidence of postoperative sore throat and
other side effects.
3.To assess serum magnesium levels in all the groups
|