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CTRI Number  CTRI/2025/07/090760 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison Of Dexmedetomidine and Fentanyl As An Adjuvant To Ropivacaine For Epidural Anaesthesia for Pain Relief in Lower Abdominal And Lower Limb Surgery. 
Scientific Title of Study   Comparative Study Of Dexmedetomidine And Fentanyl As An Adjuvant To Ropivacaine For Epidural Anaeshesia In Lower Abdominal And Lower Limb Surgery. 
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 Raj Dethaliya 
Designation  2nd Year Resident Of MD Anaesthesiology 
Affiliation  B.J. Medical College And Civil Hospital,Ahmedabad 
Address  F3 First Floor Department Of Anaesthesia Trauma Building of Civil Hospital Civil Hospital Campus Asarwa Haripura Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  8200440685  
Fax    
Email  dethaliya.raj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejal G Mehta 
Designation  Associate Professor(H.G.) Dept. Of Anaesthesia 
Affiliation  B.J. Medical College, Civil Hospital, Ahmedabad 
Address  F3 First Floor Department Of Anaesthesia Trauma Building of Civil Hospital Civil Hospital Campus Asarwa Haripura Ahmedabad
nil
Ahmadabad
GUJARAT
380016
India 
Phone  9825881489  
Fax    
Email  gjmehta17@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejal G Mehta 
Designation  Associate Professor(H.G.) Dept. Of Anaesthesia 
Affiliation  B.J. Medical College And Civil Hospital 
Address  F3 First Floor Department Of Anaesthesia Trauma Building of Civil Hospital Civil Hospital Campus Asarwa Haripura Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9825881489  
Fax    
Email  gjmehta17@yahoo.com  
 
Source of Monetary or Material Support  
Government of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
 
Primary Sponsor  
Name  Government of Gujarat 
Address  Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
Type of Sponsor  Government medical college 
 
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 
Dr Raj Dethaliya  B.J. Medical College, Civil Hospital Campus  Civil Hospital, Haripura, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT 		 8200440685

dethaliya.raj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE & CIVIL HOSPITAL, AHMEDABAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY HUMAN VOLUNTEERS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ropivacaine and Dexmedetomidine combination   As A Induction agent we use Inj. Ropivacaine(0.75%) 15 ml with Inj. Dexmedetomidine 1mcg/kg total volume of 16 ml in epidural anaesthesia. 
Comparator Agent  Ropivacaine and Fentanyl combination  As A Induction agent we use Inj. Ropivacaine(0.75%)15 ml with Inj. Fentanyl 1mcg/kg total volume of 16 ml in epidural anaesthesia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
Age : 18-75 years old
Gender : Either Male or Female
ASA physical status I-II-III
Patient undergoing for elective lower abdominal and lower limb sugery. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the duration of analgesia.  Patient Has to be monitored Intraop. as well as post op. for 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   31/07/2025 
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="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 - 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 -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) - 

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 01-01-2031?
    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   Based on the result in the present study, dexmedetomidine is found to be an effective adjuvant to ropivacaine for epidural anaesthesia as compared to fentanyl in doses of 1mcg/kg as it provide faster onset,prolonged duration of analgesia. With more incidences of hypotension, bradycardia and sedation when dexmedetomidine is used as an adjuvant. 
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