| CTRI Number |
CTRI/2026/02/104427 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two routes of drug Dexmedetomidine used for hypotensive anaesthesia during FESS Surgery in adults |
|
Scientific Title of Study
|
Comparison of Nebulized versus intravenous Dexmedetomidine for hypotensive anaesthesia during functional endoscopic sinus nasal surgery in adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod J B |
| Designation |
post graduate resident |
| Affiliation |
Dr.SN medical College jodhpur |
| Address |
Pg resident,
Department of anaesthesia
Dr SN medical College jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
7406062922 |
| Fax |
|
| Email |
pramodjbvims3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita janweja |
| Designation |
Senior professor |
| Affiliation |
Dr SN medical College jodhpur |
| Address |
Senior professor,
Department of anaesthesia
Dr SN medical College jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
Sarita.janweja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Janwaja |
| Designation |
Senior professor |
| Affiliation |
Dr SN medical College jodhpur |
| Address |
Senior professor,
Department of anaesthesia
Dr SN medical College jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
sarita.janweja@gmail.com |
|
|
Source of Monetary or Material Support
|
| MDM hospital, Dr. SN medical College jodhpur
A-5, near Central Laboratory, Sector-H, Shastri Nagar, Jodhpur, Rajasthan 342003 India |
|
|
Primary Sponsor
|
| Name |
MDM hospital, Dr. SN medical College jodhpur |
| Address |
MDM hospital,
Shastri Nagar,
Jodhpur - 342003 |
| Type of Sponsor |
Government 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 pramod |
MDM main ot , ot no 4 and ot no 5, mdm hospital , Jodhpur |
MDM main ot , department of anaesthesia,Mdm hospital jodhpur
A-5, near Central Laboratory, Sector-H, Shastri Nagar, Jodhpur, Rajasthan 342003
Jodhpur
RAJASTHAN |
7406062922
pramodjbvims3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.SNMC ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Dexmedetomidine |
Dexmedetomidine is given intravenously at 1mcg per kg in 100ml NS over 10 min 15 min before induction |
| Intervention |
Nebulized Dexmedetomidine |
Dexmedetomidine is given as nebulization at 1mcg per kg 15min before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 and above years of either sex.
2. ASA physical status I or II individuals
3. Patients undergoing elective FESS under general anaesthesia (operative duration of 60-120 minutes).
4. Patients must be able to provide written informed consent and must have no contraindications to the use of dexmedetomidine through either nebulized or intravenous routes. |
|
| ExclusionCriteria |
| Details |
Refusal of consent by the patient.
2. Patients known hypersensitivity to dexmedetomidine.
3. Patient with significant cardiovascular instability.
4. Pregnant or lactating women.
5. Patients with hepatic, renal, neurologic, or psychiatric disorders that may interfere with drug metabolism or study assessments will not be included |
|
|
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 |
| The primary objective of this study is to assess the incidence of hypotension in nebulized versus intravenous dexmedetomidine for hypotensive anaesthesia during FESS in adults. |
During the surgery at 5 min,10min, 15min,20min ,25min and till the end of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following objectives will be recorded & compared between nebulized & intravenous groups:
1. Mean arterial pressure & heart rate.
2. Intraoperative need for rescue medication for hypotension (Inj. Esmolol).
3. Intraoperative analgesics & opioid requirements.
4. Recovery parameters, including sedation levels using Ramsay Sedation Score, time to extubation, & time to discharge from PACU.
5. Incidence of adverse effects. |
At 5min,10min,15min,20min,25min,30min & till end of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2027 |
| Date of Study Completion (India) |
06/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 study compares nebulized dexmedetomidine with intravenous dexmedetomidine for providing hypotensive anesthesia in adults undergoing Functional Endoscopic Sinus Surgery (FESS). The primary objective is to assess the incidence of hypotension between the two routes of administration. Secondary outcomes include intraoperative hemodynamic stability, quality of the surgical field, anesthetic and analgesic requirements, and the incidence of adverse effects such as bradycardia and excessive sedation. By evaluating the efficacy and safety of nebulized dexmedetomidine, this study aims to determine whether it can serve as a non-invasive alternative to the intravenous route while minimizing hemodynamic complications during FESS. |