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CTRI Number  CTRI/2024/03/063409 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Magnesium Sulphate and Dexmedetomidine with Ropivacaine Heavy as its adjuvants, in Spinal Anesthesia for Infra-Umbilical surgeries and Post-operative Analgesia 
Scientific Title of Study   Comparison of Dexmedetomidine and Magnesium Sulphate as Adjuvant with Ropivacaine Heavy in Spinal Anesthesia for Infra-Umbilical surgeries and Post-operative Analgesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VANGALA VYSHNAVI 
Designation  POST-GRADUATE 
Affiliation  GOVERNMENT MEDICAL COLLEGE,ANANTAPURAMU. 
Address  GOVERNMENT MEDICAL COLLEGE,ANANTAPURURAMU,515001, ANDHRA PRADESH

Anantapur
ANDHRA PRADESH
515001
India 
Phone  9492240870  
Fax    
Email  vangalavyshnavi6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.K L SUBRAMANYAM 
Designation  PROFESSOR 
Affiliation  GOVERNMENT MEDICAL COLLEGE,ANANTAPURAMU. 
Address  GOVERNMENT MEDICAL COLLEGE, DEPARTMENT OF ANAESTHESIOLOGY,ANANTAPURURAMU, 515001, ANDHRA PRADESH.

Anantapur
ANDHRA PRADESH
515001
India 
Phone  9849014112  
Fax    
Email  dr_KLS2008@yahoo.in  
 
Details of Contact Person
Public Query  
Name  VANGALA VYSHNAVI 
Designation  POST-GRADUATE 
Affiliation  GOVERNMENT MEDICAL COLLEGE,ANANTAPURAMU. 
Address  GOVERNMENT MEDICAL COLLEGE,ANANTAPURURAMU,515001, ANDHRA PRADESH


ANDHRA PRADESH
515001
India 
Phone  9492240870  
Fax    
Email  vangalavyshnavi6@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY,GOVERNMENT MEDICAL COLLEGE,ANANTAPURAMU,ANDHRA PRADESH,515001 
 
Primary Sponsor  
Name  VYSHNAVI 
Address  GOVERNMENT MEDICAL COLLEGE,ANANTAPUR 
Type of Sponsor  Other [] 
 
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 
VANGALA VYSHNAVI  GOVERNMENT MEDICAL COLLEGE  DEPARTEMENT OF ANAESTHESIOLOGY,ANANTAPURAMU
Anantapur
ANDHRA PRADESH 		 9492240870

vangalavyshnavi6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE,ANANTHAPURAMU  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  ROPIVACAINE WITH DEXMEDETOMIDINE AND MAGNESIUM SULPHATE IN SPINAL ANAESTHESIA  ROPIVACAINE-0.75%,INTRA-THECAL DEXMEDETOMIDINE-10 MICROGRAMS,INTRA-THECAL MAGNESIUM SULPHATE-75 MG,INTRA-THECAL,DURATION-1 YEAR 
Intervention  ROPIVACAINE WITH DEXMEDETOMIDINE AND MAGNESIUM SULPHATE IN SPINAL ANAESTHESIA  ROPIVACAUNE-0.75%,INTRA-THECAL DEXMEDETOMIDINE-10 MICROGRAMS,INTRA-THECAL MAGNESIUM SULPHATE-75MG,INTRA-THECAL,DURATION-1 YEAR 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 to 60 years of either sex.
2. ASA Grade I and II.
3. Patients undergoing infra-umbilical surgeries under spinal anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patient unwillingness
2.ASA—Grade III and Grade IV
3.Allergy to given drugs
4.Local site infections
5.Pregnant women
6.Bledding disorders and cardio-pulmonary disorders.
7.Patients with neurological deficits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-operative analgesia  6hrs after each surgery,baseline 
 
Secondary Outcome  
Outcome  TimePoints 
hypotension,bradycardia,vomiting,if any.  upto 6-8hrs after surgery,baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/03/2024 
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="1"
Days="10" 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vangalavyshnavi6@gmail.com].

  6. For how long will this data be available start date provided 25-01-2025 and end date provided 25-01-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To evaluate and compare the efficacy of intrathecally administered dexmedetomidine and magnesium sulphate along with ropivacaine in patients undergoing infraumbilical surgeries and evalute the post-operative analgesic effects of both the drugs. 
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