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CTRI Number  CTRI/2025/02/080174 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 02/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between two groups of participants,both groups receiving different drug combinations during spinal anesthesia for elective gynecological surgeries.  
Scientific Title of Study   Comparison of intrathecal fentanyl and dexmedetomidine as adjuvants to hyperbaric bupivacaine for elective gynecological surgeries : A double blind controlled 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  Saikat Kundu 
Designation  Post Graduate Trainee  
Affiliation  Institute of Post Graduate Medical Education And Research, Kolkata 
Address  Department of Anaesthesiology,Institute of Post Graduate Medical Education And Research, Kolkata, 244 AJC Bose Road, Kolkata 700020 West Bengal

Kolkata
WEST BENGAL
700020
India 
Phone  7687880702  
Fax    
Email  saikat22kundu@gmil.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dibyendu Garai 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Institute of Post Graduate Medical Education And Research, Kolkata 
Address  Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road, Kolkata 700020 West Bengal

Kolkata
WEST BENGAL
700020
India 
Phone  9433181485  
Fax    
Email  dibyendugarai.dg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dibyendu Garai 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Institute of Post Graduate Medical Education And Research, Kolkata 
Address  Institute of Post Graduate Medical Education And Research, Kolkata, 244 AJC Bose Road, Kolkata 700020 West Bengal

Kolkata
WEST BENGAL
700020
India 
Phone  9433181485  
Fax    
Email  dibyendugarai.dg@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Institute of Post Graduate Medical Education And Research, Kolkata 244 AJC Bose Road, Kolkata 700020 West Bengal, India 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Institute of Post Graduate Medical Education And Research, 244 AJC Bose Road, Kolkata 700020 
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 
Saikat Kundu  Institute of Post Graduate Medical Education And Research, Kolkata   Department of Anaesthesiology, IPGMER And SSKM Hospital,244 AJC Bose Road, Kolkata 700020
Kolkata
WEST BENGAL 		 7687880702

saikat22kundu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER RESEARCH OVERSIGHT COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injecting intrathecal 25mcg fentanyl as adjuvant to 2.7ml hyperbaric bupivacaine in patients undergoing elective gynecological surgeries.  Onset and duration of sensory and motor block, assessment of intraoperative hemodynamic changes and adverse effects will be monitored in the group. 
Intervention  Injecting intrathecal 5mcg dexmedetomidine as adjuvant to 2.7ml hyperbaric bupivacaine in patients undergoing elective gynecological surgeries.  Onset and duration of sensory and motor block, assessment of intraoperative hemodynamic changes and adverse effects will be monitored in the group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. 18-60 years female patients with physical status 1 and 2 according to the American Society of Anaesthesiologists(ASA). 2. Patients undergoing Total abdominal hysterectomy (TAH), Vaginal hysterectomy (VH) and Myomectomy. 3. Providing written informed consent. 
 
ExclusionCriteria 
Details  1. Patient refusal. 2. ASA grade 3 and 4. 3. Emergency surgeries. 4. Patients with motor and/or sensory deficit. 5.Patients with anticipated difficult airway. 6.Patients having compromised cardiac,pulmonary,hepatic and renal functions. 7. Patients with seizure disorders. 8. Patients having coagulation disorders. 9. Localised skin infection at the site of injection. 10. Patients having known allergy to drugs used in this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of sensory and motor block and hemodynamic changes.  Intraoperative. 
 
Secondary Outcome  
Outcome  TimePoints 
Onset time to reach peak sensory and motor block and assessment of adverse effect.  Postprocedural. 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   14/02/2025 
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="0"
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-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saikat22kundu@gmail.com].

  6. For how long will this data be available start date provided 29-11-2024 and end date provided 29-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This trial will compare between two groups posted for electives gynecological surgeries, one receiving intrathecal dexmedetomidine and another group receiving intrathecal fentanyl as adjuvants to hyperbaric bupivacaine with respect to duration of block, intraoperative hemodynamic changes, onset time to reach peak motor and sensory block and postprocedural adverse effects. 
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