| CTRI Number |
CTRI/2025/12/099963 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Advantages of Dexmedetomidine during Third Space Endoscopy |
|
Scientific Title of Study
|
Comparison of Nebulized Dexmedetomidine and Normal Saline on haemodynamic parameters During Third Space Endoscopy : A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joseph Sebastian |
| Designation |
PG Registrar |
| Affiliation |
Aster Medcity |
| Address |
Aster Medcity, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala.
Ernakulam
KERALA
682027
India |
| Phone |
9495530842 |
| Fax |
|
| Email |
josephmachiyanickal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha A |
| Designation |
Senior Consultant |
| Affiliation |
Aster Medcity |
| Address |
Aster Medcity, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala.
Ernakulam
KERALA
682027
India |
| Phone |
9656732203 |
| Fax |
|
| Email |
drnisha.rajmohan@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisha A |
| Designation |
Senior Consultant |
| Affiliation |
Aster Medcity |
| Address |
Aster Medcity, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala.
Ernakulam
KERALA
682027
India |
| Phone |
9656732203 |
| Fax |
|
| Email |
drnisha.rajmohan@asterhospital.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Joseph Sebastian |
| Address |
Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027. |
| 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 |
| DrNisha A |
Aster Medcity |
Aster Medcity, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala.
Ernakulam
KERALA |
9656732203
drnisha.rajmohan@asterhospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulization with dexmeditomidine |
Nebulization with dexmeditomide is given at dose of 1mcg/kg , 30 minutes prior to intubation. |
| Comparator Agent |
NEBULIZATION WITH NORMAL SALINE |
Nebulization with normal saline , 30 minutes prior to intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anesthesiologists) physical status I- II,111, and undergoing third space endoscopies. |
|
| ExclusionCriteria |
| Details |
Patients with severe respiratory disease, cardiac disease, or neurological disorders, those with a history of dexmedetomidine allergy or intolerance, not willing for study, pregnancy, ASA 4 and above
,refusal of consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability with nebulized dexmedetomidine as premedication during third space endoscopy procedures, as measured by heart rate, blood pressure . |
30 minutes prior to intubation till 20 minutes after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know the hemodynamic response of nebulized dexmedetomidine as premedication for the attenuation of the laryngoscopy and intubation response
To assess the incidence of adverse events associated with nebulized dexmedetomidine such as hypotension, bradycardia
|
30 minutes prior to intubation till 20 minutes after extubation. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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 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
|
This study aims to investigate the comparative effects of nebulized dexmedetomidine and normal saline on hemodynamic parameters during third space endoscopic procedures, and to determine if nebulized dexmedetomidine offers a clinically significant advantage in maintaining hemodynamic stability compared to normal saline. |