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CTRI Number  CTRI/2021/06/034048 [Registered on: 07/06/2021] Trial Registered Prospectively
Last Modified On: 04/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of intravenous Magnesium sulfate and intravenous Tramadol for prevention of post spinal shivering in patients undergoing lower limb Orthopedic surgery. 
Scientific Title of Study   To compare the prophylactic effect of intravenous Magnesium sulfate with intravenous Tramadol on post spinal shivering for patients undergoing lower limb orthopaedic surgery under spinal anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyajeet Singh 
Designation  PG Resident 
Affiliation  Peoples college of medical sciences and research centre 
Address  Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462021
India 
Phone  8959257243  
Fax    
Email  satya_jeet97@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Mahima Batra 
Designation  Professor 
Affiliation  Peoples college of medical sciences and research centre 
Address  Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462010
India 
Phone  9752075418  
Fax    
Email  drmahimabatra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahima Batra 
Designation  Professor 
Affiliation  Peoples college of medical sciences and research centre 
Address  Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal
Sagar
MADHYA PRADESH
462010
India 
Phone  9752075418  
Fax    
Email  drmahimabatra@gmail.com  
 
Source of Monetary or Material Support  
Peoples hospital 
 
Primary Sponsor  
Name  Satyajeet Singh 
Address  Department of Anaesthesia, Peoples Hospital, PCMS&RC, Bhanpur, Bhopal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Satyajeet Singh  Peoples Hospital  Department of Anaesthesia, Peoples Hospital PCMS & RC,Bhanpur Bhopal
Bhopal
MADHYA PRADESH 
8959257243

satya_jeet97@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Magnesium sulfate (30mg/kg)  To compare the efficacy of intravenous(iv) Magnesium sulfate(30mg/kg) with intravenous(iv) Tramadol(1mg/kg) on postspinal shivering for patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.  
Comparator Agent  Tramadol (1 mg/kg)   To compare the efficacy of intravenous(iv) Magnesium sulfate(30mg/kg) with intravenous(iv) Tramadol (1mg/kg) on postspinal shivering for patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologists’ Physical Status I & II.
2.Patients posted for lower limb orthopaedic surgery under spinal anesthesia in Peoples Hospital. 
 
ExclusionCriteria 
Details  1.American Society of Anesthesiologists’ physical Status III & IV.
2.Patients with Severe cardiopulmonary, renal or liver disease
3.Morbidly obese patients
4.Basal body temperature of patiens >38°C or <36°C
5.Those who received blood transfusion or >2500 ml fluid
6.Patients Allergic to study drug
7.Patients refusing to give consent
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Tramadol and Magnesium sulfate both are equally effective in postspinal shivering.  1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Tramadol and Magnesium sulfate both are equally effective in postspinal shivering.  1 hour 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   15/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Shivering being one of the most common complication of spinal anesthesia, we want to compare the efficacy of intravenous Magnesium sulfate with intravenous Tramadol on patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia for postspinal shivering. The purpose of study to find the most efficient drug among them.

 
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