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CTRI Number  CTRI/2020/12/030033 [Registered on: 24/12/2020] Trial Registered Prospectively
Last Modified On: 22/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs in spinal anaesthesia for lower limb orthopaedic surgeries  
Scientific Title of Study   COMPARISON OF EFFECT OF ADDING INTRATHECAL MgSO4 (50%) TO BUPIVACAINE (0.5%) VERSUS DEXMEDITOMEDINE TO BUPIVACAINE (0.5%) FOR LOWER LIMB ORTHOPAEDIC SURGERIES.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meha Pathak 
Designation  2nd year Resident 
Affiliation  GMC Bhavnagar 
Address  Department of Anaesthesia, sir T hospital, bhavnagar
Department of Anaesthesia, sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9409442734  
Fax  0  
Email  pathak_meha@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa Doshi 
Designation  Associate proffesor  
Affiliation  GMC Bhavnagar 
Address  Sir T hospital bhavnagar
Department of Anaesthesia, SirT hospital bhavnagar
Bhavnagar
GUJARAT
364002
India 
Phone  9428810763  
Fax  0  
Email  drshilpadoshi@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Meha Pathak 
Designation  2nd year Resident 
Affiliation  GMC Bhavnagar 
Address  Department of Anaesthesia, Sir T hospital bhavnagar
Department of Anaesthesia, Sir T hospital bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9409442734  
Fax  0  
Email  pathak_meha@yahoo.com  
 
Source of Monetary or Material Support  
sir t hospital, bhavnagar 
 
Primary Sponsor  
Name  Department of AnaesthesiologyGoverment medical college bhavnagar 
Address  Goverment medical college bhavnagar, gujarat- 364001 
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 Meha Pathak  Sir t hospital   Department of anaesthesiology, Sir T hospital, bhavnagar
Bhavnagar
GUJARAT 		 9409442734
0
pathak_meha@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S828||Other fractures of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  Comparison of Inj. Dexmedetimidine (dose: 0.1 ml, route: intra thecal) 
Comparator Agent  Mgso4   inj. Mgso4 (dose: 50mg,0.1 ml, route: intra thecal)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grades: I, II and III.
Participant undergoing lower limb surgery under subarachnoid block.
A written informed consent obtained from participant.
 
 
ExclusionCriteria 
Details  Participants having contraindications to subarachnoid block like congenital spinal anomalies, altered coagulation profile, local site skin infection.
Participants having severe psychiatric disorders like depression, dementia or any other psychiatric illness and are not compatible for subarachnoid block.
- Participants having neurological diseases like brain tumour, CNS syphilis, meningitis.
Spinal cord and peripheral nerve diseases, poliomyelitis, multiple sclerosis.
Participants with allergy to local anaesthetic drug or study drug.
Pregnant lady and lactating mother.
Chronic headache. eg.migraine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the onset, peak, duration and regression of sensory and motor blockage in both groups.
To compare the onset, peak, duration and regression of motor blockage in both groups.
To compare period of postoperative analgesia in both groups.
 		 To measure vitals, and semsory and motor block effects at specific time interval. Time 0, after immediately giving spinal anaesthesia, and then at the time point of 1,2,3,5,10,15,30,60,90,120 mins and for post operative analgesia and effect regression 4 hours post operatively.  
 
Secondary Outcome  
Outcome  TimePoints 
to compare heamodynemic status of pt, and any side effects.  Time 0(immediately after block) and then at 1,2,3,5,10,15,30,60,90,120 mins. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   31/12/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Spinal anesthesia is the most common used technique for lower limb orthopaedic surgeries. Local anaesthetic like bupivacaine alone when used, may not be able to give longer duration of action so it is beneficial to use it with adjuvants like dexmedetomidine and Mgso4.  So in this study we are studying the effects of adding dexmedetomidine and Mgso4 as an adjuvat to bupivacaine for sub-arachnoid block. 
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