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CTRI Number  CTRI/2025/06/089525 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Faster and Better Numbing? Adding Dexmedetomidine to Spinal Anesthesia with Ropivacaine for Lower Body Operations 
Scientific Title of Study   COMPARISON OF DEXMEDITOMEDINE 10 MICROGRAM AS ADJUVANT FOR INFRAUMBILICAL SURGERY IN PATIENTS RECIEVING ROPIVACAINE 0.75% HEAVY SPINAL ANAESTHESIA: A RANDOMIZED OPEN TRIAL 
Trial Acronym  DREAM  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrHarshwardhan Tikle 
Designation  Associate Professor  
Affiliation  TNMC & BYL Nair Charitable Hospital Mumbai 
Address  Dr Harshwardhan Tikle Department of Anaesthesiology TNMC and BYL Nair Charitable Hospital Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9892404649  
Fax    
Email  tikleharshwardhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hrishikesh Sarnobat  
Designation  Junior Resident 
Affiliation  TNMC and BYL Nair Charitable Hospital Mumbai  
Address  Dr Hrishikesh Sarnobat Junior Resident Department of Anaesthesiology TNMC and BYL Nair Charitable Hospital Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  7385314002  
Fax    
Email  rushikesh.rhs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hrishikesh Sarnobat  
Designation  Junior Resident 
Affiliation  TNMC and BYL Nair Charitable Hospital Mumbai  
Address  Dr Hrishikesh Sarnobat Junior Resident Department of Anaesthesiology TNMC and BYL Nair Charitable Hospital Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  7385314002  
Fax    
Email  rushikesh.rhs@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department Of Anaesthesiology  
Address  TNMC and BYL Nair Charitable Hospital Mumbai  
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 Hrishikesh Sarnobat   TNMC AND BYL NAIR HOSPITAL Mumbai 400008  Department of Anaesthesiology, Third Floor, College Building, TNMC And BYL Nair Charitable Hospital, Anand Rao Nair Marg , Mumbai Central 400008
Mumbai
MAHARASHTRA 		 7385314002

RUSHIKESH.RHS@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for Academic Research Projects ,TNMC ,Mumbai ,400008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (2) ICD-10 Condition: S723||Fracture of shaft of femur, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: N433||Hydrocele, unspecified, (5) ICD-10 Condition: N926||Irregular menstruation, unspecified, (6) ICD-10 Condition: C530||Malignant neoplasm of endocervix, (7) ICD-10 Condition: S910||Open wound of ankle, (8) ICD-10 Condition: L894||Pressure ulcer of contiguous siteof back, buttock and hip, (9) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sub Arachnoid Block R  Participant will be administered sub arachnoid block with 3cc volume of local anaesthetic agent Ropivacaine 0.75 % Heavy  
Comparator Agent  Subarachnoid block Rd  Participants will be administered 3 cc local anaesthetic agent Ropivacaine 0.75% Heavy with Dexmedetomidine 10MCG intrathecally  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) American Society of anaesthesiologists (ASA) Grade I and II.

2) Age between 18-75 years.

3) Patient of either sex.

4) Undergoing lower limb and lower abdominal surgeries (hernias, urological surgeries, lower segment caesarean section etc.) 
 
ExclusionCriteria 
Details  Upper abdominal surgeries(incision extend above umbilicus) and cesarean sections.

Pt on LMWH and heparin therapy .

Pre-existing neurological conditions or surgeries which are waxing and waning in nature(eg: multiple sclerosis,poliomyelitis). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Additives like dexmedetomidine improves quality of sub arachnoid block in terms of Speed of onset of action, Level of Blockade Achieved and Duration of blockade   Both Sensory and Motor blockade will be assessed at 0,3,5,10,20,30,60,90,120,150,180 minutes respectively to determine Time at which T10 level achieved, Highest level achieved and Two segment regression time 
 
Secondary Outcome  
Outcome  TimePoints 
Additives like dexmedetomidine into subarachnoid block gives better post operative analgesia   Pain scores will be assessed at immediately Post operative ,Before shifting Out of post operative care unit after two hours & twenty four hours later to look of need of rescue Analgesia  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/07/2025 
Date of Study Completion (India) 03/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 31-08-2025 and end date provided 31-08-2027?
    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 study investigates the effect of adding dexmedetomidine to ropivacaine for spinal anesthesia in lower abdominal surgeries. The research team will compare two groups - one receiving standard ropivacaine and another receiving ropivacaine plus 10 mcg dexmedetomidine. The goal is to determine if the addition improves anesthesia quality by measuring onset time, block duration, and pain relief after surgery.  

The trial will include 60 patients undergoing procedures like hernia repairs, randomly assigned to either treatment group. Researchers will monitor sensory and motor block levels, vital signs, and postoperative pain scores. Patients will be followed for 24 hours after surgery to assess pain levels and need for additional pain medication. The study excludes high-risk patients and those with certain medical conditions.  

Results will be analyzed statistically to compare outcomes between the two groups. The study expects dexmedetomidine to provide faster pain relief, longer-lasting anesthesia, and better postoperative pain control. Findings could support using this drug combination to improve patient comfort during and after lower abdominal surgeries. The research follows ethical guidelines and will be conducted over 12 months at TNMC and BYL Nair Hospital in Mumbai.
 
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