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CTRI Number  CTRI/2024/08/072656 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison Of Two Drugs In Spinal Anaesthesia For Infra Umbilical Procedures. 
Scientific Title of Study   A COMPARATIVE STUDY OF INTRATHECAL ROPIVACAINE HEAVY 0.75% WITH FENTANYL VERSUS DEXMEDETOMIDINE IN PATIENTS UNDER GOING ELECTIVE INFRAUMBILICAL SURGERIES. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hardik Bhagat 
Designation  PG student 
Affiliation  Gujarat University 
Address  Gujarat cancer society hospital, Anesthesia department,Anaesthesia OPD ,room number 105,near Chamunda bridge , Ahmedabad Ahmadabad GUJARAT

Ahmadabad
GUJARAT
380025
India 
Phone  7600476657  
Fax    
Email  hardikbhagat0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepa Jadav 
Designation  Associate proffesor 
Affiliation  Gujarat University 
Address  Gujarat cancer society hospital, Anesthesia department, near Chamunda bridge , Ahmedabad

Ahmadabad
GUJARAT
380025
India 
Phone  7874145408  
Fax    
Email  drdeepa0202@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepa Jadav 
Designation  Associate proffesor 
Affiliation  Gujarat University 
Address  Gujarat Cancer Society hospital, near Chamunda bridge,Ahmedabad

Ahmadabad
GUJARAT
380025
India 
Phone  7874145408  
Fax    
Email  drdeepa0202@gmail.com  
 
Source of Monetary or Material Support  
Gujarat Cancer Society hospital, near Chamunda bridge,Ahmedabad. GUJARAT 380025 India 
 
Primary Sponsor  
Name  Gujarat Cancer Society medical hospital and research centreAhmedabadGujarat 
Address  Gujarat Cancer Society hospital, near Chamunda bridge,Ahmedabad. GUJARAT 380025 India 
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 
Dr Deepa Jadav  Gujarat Cancer Society,Medical College Hospital And Research Centre.  Room Number 105, Anaesthesia OPD,Anaesthesia Department,Ahmadabad,Gujarat.
Ahmadabad
GUJARAT 		 7874145408

drdeepa0202@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl And Dexmedetomidine  1. Route of administration:- Intrathecal 2. Dose:- Group 1:-0.75% Ropivacaine Heavy 3ml Plus injection Fentanyl 25 microgram 0.5 ml Total volume - 3.5 mL Group 2:-0.75% Ropivacaine Heavy 3ml Plus injection Dexmedetomidine 10 microgram 0.1 ml plus 0.4 mL normal saline Total volume - 3.5 mL 3. Frequency:- One time at induction of surgery. 4. Duration of intervention:- 1 year  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Asa grade 1 and 2 
 
ExclusionCriteria 
Details  Asa grade 3 and 4 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pulse
Systolic Blood Pressure
Diastolic Blood Pressure
Spo2
 		 0 min
5 min
10 min
15 min
20 min
25 min
30 min
60 min
90 min
120 min 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of Analgesia.  1 hour
2 hour
3 hour
4 hour
5 hour
6 hour  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   24/08/2024 
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="2"
Months="6"
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Data are available indefinitely at (Link to be included Ctri.nic.in).

  6. For how long will this data be available start date provided 29-08-2023 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Spinal anesthesia is most commonly used anesthesia technique for infraumbilical surgeries, and it is cost-effective with decreased hospital stay. Intrathecal isobaric ropivacaine has shorter duration of anesthesia than bupivacaine. By making, ropivacaine hyperbaric will help to achieve dense block with good postoperative analgesia. 
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