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CTRI Number  CTRI/2018/02/012114 [Registered on: 23/02/2018] Trial Registered Prospectively
Last Modified On: 22/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb surgery 
Scientific Title of Study   Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to bupivacaine in spinal anesthesia for patients undergoing lower limb orthopedic surgery:A randomized double blind clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Kumari 
Designation  Junior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences,Patna 
Address  Room no-15,1st Floor,New MDH, Indira Gandhi Institute of Medical Sciences,Patna,Bihar

Patna
BIHAR
800014
India 
Phone  9031007248  
Fax    
Email  nehascarlet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajit Gupta 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences,Patna 
Address  Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,BIHAR

Patna
BIHAR
800014
India 
Phone  9473191810  
Fax    
Email  ajpta_igims@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Ajit Gupta 
Designation  Professor 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA 
Address  Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,BIHAR

Patna
BIHAR
800014
India 
Phone  9473191810  
Fax    
Email  ajpta_igims@yahoo.co.uk  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences 
 
Primary Sponsor  
Name  Neha Kumari 
Address  Room no-15,1st Floor,New MDH, Indira Gandhi Institute of Medical Sciences,PATNA 
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 
NEHA KUMARI  Indira Gandhi Institute of Medical Sciences,Sheikhpura,PATNA-14  OT complex,first floor,Indira Gandhi Institute of Medical Sciences,Patna
Patna
BIHAR 
9031007248

nehascarlet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Medical Sciences,Sheikhpura,PATNA-14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1.ASA grade 1 and 2 patients 2.Age group 18-60 yrs of either sex 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intrathecal bupivacaine and intrathecal fentanyl   3ml(0.5%)Bupivacaine and 0.5ml(25mcg)fentanyl 
Intervention  Intrathecal bupivacaine and intrathecal magnesium sulphate  3ml(0.5%) Bupivacaine and 0.1ml magnesium sulphate 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA group 1 & 2 patients
2.Patients giving valid informed consent
3.Height 150-180cm and those undergoing lower limb orthopedic surgery  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative analgesic effect  Post-operative  
 
Secondary Outcome  
Outcome  TimePoints 
Nausea,Vomitting,Hypotension,Bradycardia,Respiratory depression,Pruritus,Urinary retention,Maximum sedation score  1min,5min,10min,15min,20min,25min,30min,35min,40min,45min,50min,55min,60min 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   22/03/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Plan to publish after completion of the study 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant  to Bupivacaine in spinal anesthesia for patients undergoing lower limb orthopedic surgery
 
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