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CTRI Number  CTRI/2025/08/093869 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To access in lower limbs surgeries done under spinal anaesthesia by hyperbaric levobupivacaine, will IV infusion of dexmedetomidine affect the analgesia . 
Scientific Title of Study   Effect of Intravenous Dexmedetomidine infusion on total duration of analgesia in patients receiving intrathecal hyperbaric levobupivacaine in lower limb surgeries: Randomized Controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSimran Jakhar 
Designation  PG Resident 
Affiliation  Adesh Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India

Bathinda
PUNJAB
151001
India 
Phone  8094050545  
Fax    
Email  simranjakhar001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrShilpa Bansal 
Designation  Professor  
Affiliation  Adesh Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India

Bathinda
PUNJAB
151001
India 
Phone  9915433522  
Fax    
Email  bansalshilpa304@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrShilpa Bansal 
Designation  Professor  
Affiliation  Adesh Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India


PUNJAB
151001
India 
Phone  9915433522  
Fax    
Email  bansalshilpa304@gmail.com  
 
Source of Monetary or Material Support  
Adesh university , Bathinda , 151001 , punjab , india  
 
Primary Sponsor  
Name  Adesh university  
Address  Adesh Institute of Medical Sciences and Research, bathinda , punjab 151001 
Type of Sponsor  Private 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 
DrSimran Jakhar  Adesh Institute of Medical Sciences and Research   OT Complex of Anaesthesiology and Intensive care department
Bathinda
PUNJAB 		 8094050545

simranjakhar001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Adesh University   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 
Intervention  Dexmedetomidine  Effect of intravenous dexmedetomidine infusion on total duration(till the patient starts complaining of the pain) of analgesia in patients receiving intrathecal hyperbaric levobupivacaine in lower limb surgeries 
Comparator Agent  Dexmedetomidine vs normal saline  Effect of intravenous dexmedetomidine infusion on total duration of analgesia in patients receiving intrathecal hyperbaric levobupivacaine in lower limb surgeries 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with age 20 to 60 yrs ; All genders ; ASA Grading I , II ; Elective lower limb surgeries
under spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient refusing to spinal block , pregnants , uncontrolled disease ,spine trauma  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare sensory and motor nerve block characteristics (onset, duration and recovery) in both
groups. 		 3min time interval at starting 30min then 5min for next 30min and then 15min  
 
Secondary Outcome  
Outcome  TimePoints 
To assess hemodynamic parameters in perioperative period.
To monitor and treat the complications in perioperative period. 		 3min time interval at starting 30min then 5min for next 30min and then 15min  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   09/09/2025 
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 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-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

  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 - Proposals should be directed to [simranjakhar001@gmail.com].

  6. For how long will this data be available start date provided 28-08-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

There are very few studies showing effect of IV Dexmedetomidine on sensory and motor block

characteristics. Further research is warranted to determine optimal dosing, timing, and patient characteristics

that maximize benefits.

As opioid sparing technique have become popular , we planned to conduct a study in patients receiving

intrathecal levobupivacaine for elective lower limb surgeries with or without use of intravenous infusion of

dexmedetomidine. We will evaluate efficacy and safety of intravenous dexmedetomidine on duration of

effective analgesia. In our study we will compare onset, duration, recovery of sensory and motor block,

hemodynamic parameters as well as perioperative complications


 
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