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CTRI Number  CTRI/2024/10/074690 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs in drugs in segmental spinal anesthesia in patients undergoing breast surgeries. 
Scientific Title of Study   Comparison of Dexmedetomidine Versus Fentanyl as Adjuvant Along With Isobaric Levobupivacaine(0.5percent) In Segmental Spinal Anaesthesia In Patients Undergoing Breast 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  AASTHA JUNEJA 
Designation  Junior Resident 
Affiliation  Sardar Patel Medical college,Bikaner 
Address  Department of Anaesthesia Sardar Patel Medical College bikaner

Bikaner
RAJASTHAN
334001
India 
Phone  09050003917  
Fax    
Email  aastha17juneja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Pareek 
Designation  Add. Principal and Head of the Department 
Affiliation  Sardar Patel Medical college,Bikaner 
Address  Department of Anaesthesia Sardar Patel Medical college Bikaner Rajasthan 334001
Sardar Patel Medical college Bikaner Rajasthan 334001
Bikaner
RAJASTHAN
334001
India 
Phone  982810281  
Fax    
Email  dranitapareek23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ANITA PAREEK 
Designation  Add. Principal and Head of the Department 
Affiliation  Sardar Patel Medical college,Bikaner 
Address  Department of Anaesthesia Sardar Patel Medical college Bikaner Rajasthan 334001
Sardar Patel Medical college Bikaner Rajasthan 334001
Bikaner
RAJASTHAN
334001
India 
Phone  982810281  
Fax    
Email  dranitapareek23@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical College Bikaner 334001,Rajasthan India 
 
Primary Sponsor  
Name  Sardar Patel Medical College Bikaner 
Address  Sardar Patel Medical college Bikaner Rajasthan 334001  
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 Aastha Juneja  Sardar Patel Medical college,Bikaner  Sardar Patel Medical college Bikaner Rajasthan 334001
Bikaner
RAJASTHAN 		 09050003917

aastha17juneja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Reasearch Board ,SPMC Bikaner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D493||Neoplasm of unspecified behavior of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Segmental Spinal anaesthesia at level T4-T5 for Breast surgery less than 2 hrs  Segemental Spinal Anaesthesia at level T4-T5 with Inj Levobupivacaine(0.5%)1ml and 0.5 ml fentanyl  
Intervention  Segmental spinal anaesthesia at T4 T5 level for breast surgeries less than 2 hrs.  Segmental Spinal Anaesthesia at level T4-T5 with Inj Levobupivacaine(0.5%)1ml and 5 mcg dexmedetomidine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I/II
patients undergoing elective breast surgery
surgical procedure less than 2 hrs 
 
ExclusionCriteria 
Details  age less than 18 yrs or more than 60 yrs
known allaergy to drug
patient refusal
spinal locomotor or bleeding disorder
patients on anticoagulants 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy and hemodynamic stability of isobaric levobupivacaine 1 ml (0.5%)with dexmedetomidine 5 mcg and isobaric levobupivacaine 1ml (0.5%) with fentanyl 25mcg in segmental spinal anaesthesia in patients undergoing breast surgeries.To determine the onset of sensory and motor block.
➢ To determine the duration and quality of sensory and motor block.
 		 till the drug effect is over 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the hemodynamic variables: systolic blood pressure , diastolic blood pressure, mean arterial pressure, pulse rate, SpO2.
➢ To observe the duration of post operative analgesia.
➢To observe any side effects and complications related to drugs and technique.
➢To observe surgeon’s and patient’s satisfaction
 		 till 24 hrs 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) 15/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/03/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 15-10-2025 and end date provided 15-10-2026?
    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
Modification(s)  		 General Anaesthesia is standard technique of anaesthesia for breast surgeries.Risk of General anaesthesia is more in some cases.Segmental spinal is the new and effective modality.
Our study tends to compare fentanyl and dexmedetomidine as adjuvants along with Isobaric levobupivacaine for segmental spinal in breast surgeries.
 
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