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CTRI Number  CTRI/2025/01/079667 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Prospective Randomized comparative study of Inj Dexmedetomidine and Inj Fentanyl for conscious sedation in Middle Ear Surgery under Monitored Anesthesia Care. 
Scientific Title of Study   A COMPARATIVE STUDY OF IV DEXMEDETOMIDINE INFUSION VERSUS IV FENTANYL INFUSION FOR CONSIOUS SEDATION DURING MIDDLE EAR SURGERIES UNDER MONITORED ANAESTHESIA CARE-A RANDOMIZED CONTROLLED PILOT 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  Sandhya Khwaunju 
Designation  Anaesthesia resident 
Affiliation  Armed Forces Medical college,Pune 
Address  Armed Forces Medical College,Southern command ,Solapur -Pune Highway near Race course, Block no 1/10 Maharastra 411040

Pune
MAHARASHTRA
411040
India 
Phone  6287765631  
Fax    
Email  sndyakhwaunju03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajit Bhardwaj 
Designation  Neuroanaesthesiologist 
Affiliation  Armed Forces Medical college,Pune 
Address  Armed Forces Medical College,Southern command ,near race course,Department of Anaesthesiology and critical care ,LH-14,Pune,Maharastra 411040
Armed Forces Medical College,Southern command ,near race course,Department of Anaesthesiology and critical care ,LH-14,Pune,Maharastra 411040
Pune
MAHARASHTRA
411040
India 
Phone  8171505533  
Fax    
Email  rainaajit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ajit Bhardwaj 
Designation  Neuroanaesthesiologist 
Affiliation  Armed Forces Medical college,Pune 
Address  Armed Forces Medical College,Southern command ,near race course,Department of Anaesthesiology and critical care ,LH-14,Pune,Maharastra 411040
Armed Forces Medical College,Southern command ,near race course,Department of Anaesthesiology and critical care ,LH-14,Pune,Maharastra 411040
Pune
MAHARASHTRA
411040
India 
Phone  8171505533  
Fax    
Email  rainaajit@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College,Pune,Maharastra,411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Armed Forces Medical College,Pune,Maharastra,411040 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sandhya Khwaunju  Armed Forces Medical College  Armed Forces Medical College,Pune,Maharastra
Pune
MAHARASHTRA 		 06287765631

sndyakhwaunju03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H721||Attic perforation of tympanic membrane,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Age: 18-60 years
• Patients of either sex
• ASA Grade: I and II
• Patients undergoing middle ear surgeries under local anesthesia with MAC
• Patients consenting to the procedure
 
 
ExclusionCriteria 
Details  Pregnancy and Lactating women
Patients with Asthma
Patients on Beta Blocker drugs
MI in last 6 months, AF, Heart blocks
Deranged renal profile
Advanced liver disease (liver enzymes twice the normal range or higher)
• History of chronic use of sedatives, narcotics and alcohol
• Known sensitivity to Lignocaine or allergy to study drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
comparision of intraoperative sedation using the Ramsay Sedation Score,hemodynamic stability   Intraoperative sedation using the Ramsay Sedation Score at 5 minutes, 15 minutes, and 30 minutes after the initiation of infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
• To assess intraoperative and postoperative analgesia.
• To assess intraoperative hemodynamic stability.
• To assess the quality of the surgical field for the surgeon’s satisfaction.
• To assess the need for rescue analgesia.
• To assess any side effects, if present.
 		 5 minutes, 15 minutes, and 30 minutes after the initiation of infusion. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/02/2025 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included sndyakhwaunju03@gmail.com).

  6. For how long will this data be available start date provided 30-10-2025 and end date provided 30-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A comparative randomized controlled pilot study examining IV dexmedetomidine versus IV fentanyl infusion for conscious sedation during middle ear surgery under monitored anesthesia care.Patients randomly divided into two groups Group D (IV dexmedetomidine) and Group F(IV fentanyl )
Monitored hemodynamic parameters
Assessed sedation levels using Ramsay Sedation Scale
Evaluated post-operative recovery, pain, and satisfaction scores
 
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