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CTRI Number  CTRI/2022/05/042400 [Registered on: 06/05/2022] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study is about comparing two drugs Dexmedetomidine and Magnesium sulphate with Levobupivacaine in spinal anesthesia for lower limb surgeries 
Scientific Title of Study   Comparison of efficacy Of intrathecal Dexmedetomidine and Magnesium sulphate as adjuvants to Isobaric levobupivacaine in lower limb orthopaedic surgeries: A prospective randomised 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  Brahmbhatt Vidhi Narendrakumar 
Designation  Resident Doctor 
Affiliation  Goverment Medical College,Vadodara 
Address  Department of Anesthesiology,New surgical block,SSG hospital,Anandpura,Vadodara,Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9726800401  
Fax    
Email  brahmbhattvidhi15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKashmira Pander 
Designation  Assistant Professor 
Affiliation  Government Medical college, Vadodara 
Address  Department Of Anesthesiology,New surgical block,SSG hospital,Anandpura,Vadodara,Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9099045151  
Fax    
Email  dr.kashmira13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Brahmbhatt Vidhi Narendrakumar 
Designation  Resident Doctor 
Affiliation  Goverment Medical College,Vadodara 
Address  Department of Anesthesiology,New surgical block,SSG hospital,Anandpura,Vadodara,Gujarat

Vadodara
GUJARAT
390001
India 
Phone  9726800401  
Fax    
Email  brahmbhattvidhi15@gmail.com  
 
Source of Monetary or Material Support  
Goverment medical college baroda 
 
Primary Sponsor  
Name  Government Medical CollegeBaroda 
Address  Department of Anaesthesiology,SSG Hospital,Vadodara 
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 Vidhi  Government Medical college,Baroda  Orthopaedics operation theatre, 1st floor, New surgical building, SSG Hospital, Anandpura.
Vadodara
GUJARAT 		 9726800401

brahmbhattvidhi15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee for biomedical and health research,medical college and ssg hospital,Baroda  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  dexmedetomidine with levobupivacaine for spinal anesthesia  Dexmeditomedine 1O mcg of total O.5 ML with levobupivacaine isobaric(O.5%)2.5 ml given in spinal anesthesia for lower limb orthopedic surgeries 
Intervention  Magnesium sulphate with levobupivacaine for spinal anesthesia  Magnesium sulphate 75mg of total 0.5ml with Levobupivacaine isobaric(0.5%) 2.5ml given in spinal anesthesia for lower limb orthopedic surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA grade I,II,III
2.Lower limb orthopedic surgeries
3.Duration of surgery 2.5 to 3 hours 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Patient on beta blockers and calcium channel blockers
3.Uncontrolled systemic disease
4.Patient on anti coagulant therapy
5.Pragnant and lactating females
6.Patient with local site infection
7.Patient with allergy to local anesthetics and adjuvants 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
sensory and motor block characteristics
1.onset of sensory block at L1 dermatomal level(min)
2.Time to achieve maximum sensory level(mins)
3.Time for two segment regression(mins)
4.Total duration of sensory block(time to regress till S1 dermatome
5.Onset of motor blockade(Bromage 1)(min)
6.Maximum bromage score(Bromage 3)(mins)
7.Time to achieve maximum motor blockade(mins)
8.duratin of motor blockade(mins) 		 Throught surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To observe any changes in hemodynamic parameters like pulse rate,blood pressure,respiratory rate,ECG,spo2 perioperatively
2.Duration of effective analgesia-time from administration of drug intrathecally to pain score VAS4 postoperatively
3.Requirment of rescue analgesia in 24 hours
4.To observe any complications like bradycardia,hypotension,respiratory depression,shivering,nausea,vomiting,dryness of mouth,urinary retension etc. 		 Immediate post-op,30 min,1hr,2hr,4hr,8hr,12hr,16hr,20hr,24hr 
 
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   N/A 
Date of First Enrollment (India)   10/05/2022 
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="0"
Months="8"
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   This study carry out in Goverment medical college,Baroda.The purpose of study is to compare efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in spinal anesthesia to see the differences in sensory and motor block characteristics,mainly onset and duration of block along with determining effects on haemodynamics in lower limb orthopedic surgeries. 
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