| CTRI Number |
CTRI/2025/10/096405 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Dexmedetomidine and Propofol sedation for Evaluating the upper airway in patients with Obstructive Sleep Apnea |
|
Scientific Title of Study
|
A Comparative Study Using Dexmedetomidine Continuous Infusion versus TCI-Propofol for Patients Undergoing DISE – A Single-Centre Prospective Observational 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 |
Habeeb Rizwan |
| Designation |
Consultant |
| Affiliation |
AIG Hospitals |
| Address |
AIG Hospitals
66/AIG/2to5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA
500032
India |
| Phone |
9052126261 |
| Fax |
|
| Email |
r.habeeb@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Habeeb Rizwan |
| Designation |
Consultant |
| Affiliation |
AIG Hospitals |
| Address |
AIG Hospitals
66/AIG/2to5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032
TELANGANA
500032
India |
| Phone |
9052126261 |
| Fax |
|
| Email |
r.habeeb@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Habeeb Rizwan |
| Designation |
Consultant |
| Affiliation |
AIG Hospitals |
| Address |
AIG Hospitals
66/AIG/2to5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032
TELANGANA
500032
India |
| Phone |
9052126261 |
| Fax |
|
| Email |
r.habeeb@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIG Hospitals |
| Address |
66/AIG/2to5, Mindspace Road,Gachibowli, Hyderabad, Telangana 500032 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrHabeeb Rizwan |
AIG Hospitals |
4th Floor, OT Complex, Department of Anesthesia and Critical Care, AIG Hospitals
66/AIG/2to5, Mindspace Road, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
9052126261
r.habeeb@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committe-Asian Institute Of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diagnostic Study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine Infusion |
Loading dose of 1mcg/kg over 10 minutes followed by maintenance infusion at 0.2-0.7mcg/kg/hr during DISE Study |
| Intervention |
Target-Controlled infusion (TCI) Propofol |
Target effect site concentration of 2-4mcg/ml using TCI pump during DISE Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with OSA requiring evaluation of Upper Airway collapse during sleep |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age <18yrs or >65yrs
3. ASA status > III
4. Severe Obesity BMI > 40kg/m2
5. Known Allergy to dexmedetomidine or propofol |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of sedation quality and hemodynamic stability between Dexmedetomidine infusion and TCI Propofol during Drug-Induced Sleep Endoscopy, assessed using BIS Score |
1.Baseline (Pre-sedation)
2.After achieving the target Sedation
3.Every 5 minutes during the procedure
4.Immediate post-procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of acute upper airway collapse requiring airway adjuncts & oxygen support |
Observed till 30 minutes post-injection |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
02/11/2025 |
| 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="2"
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
|
Title:
A comparative study using Dexmedetomidine continuous infusion with TCI-Propofol for patients undergoing Drug-Induced Sleep Endoscopy (DISE) – A single centre prospective randomized controlled trial
Background:
Obstructive sleep apnea (OSA) is a common disorder causing upper airway collapse during sleep, leading to cardiovascular risks and reduced quality of life. DISE is a diagnostic procedure performed under sedation to mimic natural sleep and assess airway obstruction sites to guide surgical treatment.
Objective:
To compare the efficacy and safety of Dexmedetomidine infusion versus Target Controlled Infusion (TCI) with Propofol in obtaining optimal sedation for DISE.
Methods:
Adult patients (18-60 years) with OSA scheduled for DISE were randomized into two groups: Dexmedetomidine infusion and Propofol TCI. Sedation was titrated to a BIS score between 50-70. Primary outcomes included time to achieve sedation without apnea and recovery time. Secondary outcomes were incidences of acute airway collapse and hemodynamic instability.
Study Design:
Randomized, parallel group, active-controlled trial conducted at AIG Hospitals, Hyderabad. Allocation was concealed using sequentially numbered, sealed, opaque envelopes.
Ethical Considerations:
Informed consent was obtained from all participants. The study adhered to ethical principles ensuring patient safety, confidentiality, and rights. |