| CTRI Number |
CTRI/2026/01/101922 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Nebulised Fentanyl, Dexmedetomidine and Magnesium to Control Heart Rate and Blood Pressure During Intubation in Adult Surgical Patients |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF NEBULISED FENTANYL, DEXMEDETOMIDINE, AND MAGNESIUM SULPHATE IN MODULATING HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION: AN OPEN LABLE, RANDOMIZED, THREE WAY STUDY |
| 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 CHARAN L |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL
BLDE (DEEMED TO BE UNIVERSITY)
BIJAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
9900222004 |
| Fax |
|
| Email |
drcharanlokesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY V KATTI |
| Designation |
PROFESSOR |
| Affiliation |
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL
BLDE (DEEMED TO BE UNIVERSITY)
BIJAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
9844585900 |
| Fax |
|
| Email |
drvijaykatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHARAN L |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL
BLDE (DEEMED TO BE UNIVERSITY)
BIJAPUR
KARNATAKA
586103
India |
| Phone |
9900222004 |
| Fax |
|
| Email |
drcharanlokesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr CHARAN L |
| Address |
DEPARTMENT OF ANAESTHSEIOLOGY SHRI B.M PATIL MEDICAL COLLEGE BLDE(DEEMED TO BE UNIVERSITY) BIJAPUR |
| 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 CHARAN L |
Shri B. M. Patil Medical College |
DEPARTMENT OF ANAESTHESIOLOGY
B.L.D.E. (DEEMED TO BE UNIVERSITY) SHRI B. M. PATIL MEDICAL COLLEGE
Bijapur
KARNATAKA |
9900222004
drcharanlokesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI BM PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
MODULATING HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION |
| Comparator Agent |
FENTANYL |
MODULATING HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION |
| Comparator Agent |
MAGNESIUM SULPHATE |
MODULATING HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged between 18 and 60 years scheduled for elective surgeries requiring endotracheal intubation under general anaesthesia.
2. Classified as American Society of Anesthesiologists (ASA) physical status I or II.
3. Patients with Mallampati airway classification Grade I or II.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known drug allergies to study drugs,
2. Individuals with a body mass index (BMI) greater than 30 kg/m²,
3. History of severe cardiovascular diseases (such as ischaemic heart disease or uncontrolled hypertension),
4. Patients with a history of alcohol intake or chronic drug use,
5. Pregnant women
6. Cases where tracheal intubation time exceeded 20 seconds.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in heart rate (HR) from the baseline (before nebulisation) to two minutes after tracheal intubation following administration of nebulised fentanyl, dexmedetomidine, or magnesium sulphate. |
before nebulization to 2 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse variations in
Systolic Blood Pressure (SBP),
Diastolic Blood Pressure (DBP), and
Mean Arterial Pressure (MAP)
|
before nebulization , after nebulization , 2mins 5mins and 10mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
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
|
This double-blinded, randomised comparative study evaluated the effectiveness of nebulised fentanyl, dexmedetomidine, and magnesium sulphate in attenuating the haemodynamic (pressor) response to laryngoscopy and tracheal intubation. Ninety ASA I–II adult patients undergoing elective surgery were randomised into three groups to receive nebulisation with fentanyl 1 µg/kg, dexmedetomidine 1 µg/kg, or magnesium sulphate 40 mg/kg prior to induction of anaesthesia. Heart rate (HR), systolic, diastolic and mean arterial blood pressure (SBP, DBP, MAP) were recorded at baseline, post-nebulisation, and at 2, 5 and 10 minutes after intubation.
The study found that dexmedetomidine and magnesium sulphate were superior to fentanyl in blunting the pressor response. An increase in HR after intubation was observed only in the fentanyl group, whereas HR remained at or below baseline in the dexmedetomidine and magnesium groups. All three groups showed a decreasing trend in SBP, DBP and MAP, but the reductions were more consistent and statistically significant with dexmedetomidine and magnesium. Adverse effects were minimal, with only occasional hypotension in the magnesium group. |