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CTRI Number  CTRI/2023/10/058679 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 14/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of fentanyl vs dexmedetomide as adjuvant to 0.5% Bupivacaine hyperbaric in spinal anaesthesia for total hip replacement surgeries.  
Scientific Title of Study   Comperative study of dexmedetomidine and fentanyl as an adjuvant to 0.5% Bupivacaine in spinal anesthesia in patient under going for total hip replacement 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  Ved jain 
Designation  Pg resident 
Affiliation  peoples college of medical sciences and research center 
Address  First floor Anaesthesia department Peoples hospital pcms campus bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  8802977828  
Fax    
Email  vedjain2004@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  ABHILEKH JAIN  
Designation  Professor  
Affiliation  peoples college of medical sciences and research center 
Address  Room 1 anaesthesia department first floor peoples hospital PCMS CAMPUS BHOPAL

Bhopal
MADHYA PRADESH
462037
India 
Phone  9827606268  
Fax    
Email  jainabhilekh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  VED JAIN 
Designation  PG RESIDENT 
Affiliation  peoples college of medical sciences and research center 
Address  Room no 1 First floor anaesthesia department PCMS CAMPUS BHOPAL

Bhopal
MADHYA PRADESH
462037
India 
Phone  8802977828  
Fax    
Email  vedjain2004@yahoo.co.in  
 
Source of Monetary or Material Support  
Anaesttesia department 1st floor Peoples college of Medical Science and research center bhopal 
 
Primary Sponsor  
Name  Peoples college of medical science 
Address  Peoples college of medical science Peoples campus Bhanpur bhopal 
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 
Ved jain   Peoples hospital  First floor anaesthesia department peoples hospital bhopal
Bhopal
MADHYA PRADESH 		 08802977828

vedjain2004@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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   Using dexmedetomidine as an adjuvant to o.5% Bupivacaine heavy for spinal anaesthesia in total hip replacement surgeries for 3 hours 
Comparator Agent  FENTANYL  Adding fentanyl as an adjuvant to o.5% bupivacaine heavy in spinal anesthesia pt under going for total hip replacement surgeries for 3 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 Age > 18 years
2 ASA grade1 and 2
3 Scheduled for elective total Hip replacement surgeries under subarachnoid block.

 
 
ExclusionCriteria 
Details  1Lack of patient’s consent.
2 Age <18yrs
3 ASA grade 3 and more.
4 Patients with local skin site infections.
5 Patients with hypersensitivity to any of the drugs used.
- Pregnant and lactating mothers.
- History of serious pulmonary disease, ischemic heart disease, renal/hepatic dysfunction, coronary artery, or cervical spine disease and patients with abnormal coagulation profile.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Post operative relief in pain   5 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate changes  5 hours 
 
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)   30/10/2023 
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 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 - NO
Brief Summary   We will be comparing two adjuvant dexmedetomidine and fentanyl when added to 0.5% Bupivacaine in patient  posted for tolat hip replacement surgeries in spinal anaesthesia for purpose of trial.
Since there are no such study has been done in Central india.
 
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