FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077026 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two doses of Dexmedetomidine with ropivacaine for Cesarean section pain relief 
Scientific Title of Study   Effect of intrathecal dexmedetomidine (3µg vs 5µg) as an adjuvant to hyperbaric ropivacaine in cesarean section: A randomized double blind clinical 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  Praveen Rathod 
Designation  Resident doctor 
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology OT block 2nd floor SSG hospital Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9449602799  
Fax    
Email  praveendrpraveen007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jyotsna F Maliwad 
Designation  Assistant Professor  
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology OT block 2nd floor SSG hospital Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9879541238  
Fax    
Email  dr.mantujr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jyotsna F Maliwad 
Designation  Assistant Professor  
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology OT block 2nd floor SSG hospital Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9879541238  
Fax    
Email  dr.mantujr@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology OT block 2nd floor SSG hospital Vadodara 390001 Gujarat. 
 
Primary Sponsor  
Name  Government Medical College Baroda 
Address  Department of Anaesthesiology OT block 2nd floor SSG hospital Vadodara 390001 Gujarat. 
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 Praveen Rathod  SSG hospital   Cesarean section OT 1st floor Rukmini building SSG hospital Vadodara 390001 Gujarat
Vadodara
GUJARAT 		 9449602799

praveendrpraveen007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for biomedical and health research, government medical College Baroda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ROPIVACAINE+3µg DEXMEDETOMIDINE  The spinal anesthesia procedure is performed under aseptic and antiseptic conditions. A 23-gauge needle is used to administer 2cc of ropivacaine heavy combined with 3µg dexmedetomidine in the L3-L4 space. The total injected volume is 2.0cc. The anesthesias effectiveness is then evaluated by assessing motor and sensory responses. 
Comparator Agent  ROPIVACAINE+5µg DEXMEDETOMIDINE  The spinal anesthesia procedure is performed under aseptic and antiseptic conditions. A 23-gauge needle is used to administer 2cc of ropivacaine heavy combined with 3µg dexmedetomidine in the L3-L4 space. The total injected volume is 2.0cc. The anesthesias effectiveness is then evaluated by assessing motor and sensory responses. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Age Group – 18 years to 40 years
2.ASA – I/II
3.Elective Caesarean section
 
 
ExclusionCriteria 
Details  1.Patients Refusal
2.Multifetal pregnancy
3.Heart block & ventricular dysfunction
4.Patient on anticoagulant therapy
5.Patient with local site infection
6.Patients with allergy to study drugs
7.Fetal distress in utero.
8.Severe hypovolemia.
9.Severe operative blood loss expected. (Placenta Previa, Accrete etc.)
10.Height less than or equal to 150cm 
 
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 
1.Monitoring of spinal characteristics (sensory and motor blockade, satisfaction of spinal anesthesia, visceral traction response, the quality of abdominal muscle relaxation and shivering & sedation score)
2.Hemodynamic stability (intraoperative) 		 Till 24hrs  
 
Secondary Outcome  
Outcome  TimePoints 
1.Postoperative analgesia score (VAS SCORE)
2. Apgar score of neonates 		 Till 24hrs 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 4 
Date of First Enrollment (India)   29/11/2024 
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-identification.

  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 [praveendrpraveen007@gmail.com].

  6. For how long will this data be available start date provided 12-11-2024 and end date provided 12-08-2025?
    Response - Immediately following publication. No end date.

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

We first determined whether dexmedetomidine combined with intrathecal hyperbaric ropivacaine could improve Hemodynamic stability during cesarean section with block characteristics and prolong postoperative sensory block with no effect on the motor block. Then, we determined which dose of dexmedetomidine was better.

 
Close