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CTRI Number  CTRI/2013/08/003864 [Registered on: 02/08/2013] Trial Registered Retrospectively
Last Modified On: 31/07/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of two medicines used during anaesthesia for treatment of shivering 
Scientific Title of Study   A comparative study of Dexmedetomidine and tramadol for the treatment of post-spinal anaesthesia shivering 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Tayal 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab 
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab

Ludhiana
PUNJAB
141001
India 
Phone  919815528855  
Fax    
Email  geetatmittal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Geeta Tayal 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab

Ludhiana
PUNJAB
141001
India 
Phone  919815528855  
Fax    
Email  geetatmittal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Geeta Tayal 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Ludhiana, Punjab

Ludhiana
PUNJAB
141001
India 
Phone  919815528855  
Fax    
Email  geetatmittal@yahoo.co.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dayanand Medical College Hospital Civil Lines Ludhiana 
Address  Civil Lines, Ludhiana, Punjab, India 
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 
Dr Geeta Tayal  Department of anaesthesia, Operation Theatre, Post-op recovery room, Dayanand Medical Hospital  Dayanand Medical College and Hospital Civil Lines Ludhiana
Ludhiana
PUNJAB 		 919815528855

geetatmittal@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dayanand Medical College & Hospital, Ludhiana   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing spinal anesthesia and experiencing post spinal shivering,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  dexmedetomidine  we wish to compare efficacy, potency and adverse effects of the Tramadol 0.5 mg/kg intravenous bolus with dexmedetomidine 0.5 µg/kg intravenous bolus in post-anaesthesia shivering. In case there was recurrence of shivering, patients were treated with additional dose of dexmedetomidine (0.5 μg/kg IV) or tramadol (0.5 mg/kg IV) in the respective groups 
Intervention  tramadol   we wish to compare efficacy, potency and adverse effects of the Tramadol 0.5 mg/kg intravenous bolus with dexmedetomidine 0.5 µg/kg intravenous bolus in post-anaesthesia shivering. In case there was recurrence of shivering, patients were treated with additional dose of dexmedetomidine (0.5 μg/kg IV) or tramadol (0.5 mg/kg IV) in the respective groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  50 ASA grade-l & II patients of either gender aged 18 to 65 years scheduled for elective as well as emergency lower abdominal, lower limb, orthopaedic and plastic surgeries under spinal anaesthesia were included in the study. 
 
ExclusionCriteria 
Details  Patients with known hypersensitivity to Dexmedetomidine or Tramadol, cardio-pulmonary, renal or hepatic disease, hyperthyroidism, psychiatric disorder, urinary tract infection, severe diabetes or autonomic neuropathies, known history of substance or alcohol abuse, patients receiving any pre-medication were not be included in the study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cessation of shivering  time of cessation of shivering 
 
Secondary Outcome  
Outcome  TimePoints 
level of sedation  intra and post-operative 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Post-spinal anaesthesia shivering is a frequent complication which can endanger the haemodynamic stability and recovery of patients. A number of drugs are being used out of which tramadol is an established agent. However, there is no ideal anti-shivering agent as the use of available drugs is associated with various adverse effects. The anti-shivering potential of dexmedetomidine is being explored recently in various trials which indicati it to be efficacious as well as free from any major adverse effect. We plan to do a randomised, controlled clinical study to compare the efficacy, potency, adverse and haemodunamic effects of tramadol and dexmedetomidine in 50 patients after IEC approval and written informed consent from each patient.    
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