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CTRI Number  CTRI/2014/11/005220 [Registered on: 25/11/2014] Trial Registered Retrospectively
Last Modified On: 21/11/2014
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 among three different doses of dexmedetomidine for prevention of shivering in patients undergoing turp under spinal anesthesia  
Scientific Title of Study   Randomised double blind comparative study of three different doses of iv dexmedetomidine for prevention of post spinal anesthesia shivering in patients undergoing transurethral resection of prostate  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fahd Hossain  
Designation  DNB Anaesthesia Trainee  
Affiliation  National Board of Examination, New Delhi  
Address  Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna -800014

Patna
BIHAR
800014
India 
Phone  9934736951  
Fax    
Email  fahdhossain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati  
Designation  Assistant Professor  
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna  
Address  Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna -800014

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  deepakswat@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Fahd Hossain  
Designation  DNB Anaesthesia Trainee  
Affiliation  National Board of Examination, New Delhi  
Address  Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna -800014

Patna
BIHAR
800014
India 
Phone  9934736951  
Fax    
Email  fahdhossain@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences  
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences Patna  
Address  Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna -800014 
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 
Fahd Hossain   Indira Gandhi Institute of Medical Sciences   Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna - 800014
Patna
BIHAR 		 9934736951

fahdhossain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of ASA grade 1 and 2 aged 50-75yrs,undergoing TURP under spinal anesthesia.The drug is being studied for prevention of shivering and for best possible dose.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine intravenously   Group P -dexmedetomidine given as iv 0.5 microgram/kg bwt. Drug given as iv diluted in 50 ml normal saline given over 10 mins just after spinal anesthesia  
Intervention  Dexmedetomidine intravenously   Group Q - dexmedetomidine given as iv 0.75microgram /kg bwt diluted in 50 ml normal saline, given over 10 mins just after spinal anesthesia.  
Intervention  Dexmedetomidine intravenously   Group R - dexmedetomidine given as iv 1.0 microgram / kg bwt diluted in 50 ml normal saline given over 10 mins just after spinal anesthesia.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  Age gr-50 to 75 yrs
Patients undergoing TURP
ASA 1 and 2
Those willing to give written consent  
 
ExclusionCriteria 
Details  Allergic to drugs,Contraindications to spinal anesthesia,treatment with alpha blockers,opioids or sedatives use,endocrinal,Cardiopulmonary,hepatic,renal,neurological,psychological disorders,blood transfusion during surgery,initial body temperature >38 or <36C,severe bradycardia or hypotension. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate minimum effective dose of intravenous dexmedetomidine to prevent shivering in patients undergoing TURP under spinal anesthesia , to observe other effects like sedation, hypotension, bradycardia   2 years  
 
Secondary Outcome  
Outcome  TimePoints 
To observe effects like sedation, hypotension, bradycardia   2years 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 4 
Date of First Enrollment (India)   07/11/2014 
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)  Open to Recruitment 
Publication Details   Not published  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   150 patients, aged 50-75 yrs,undergoing TURP under spinal anesthesia,will be divided into three groups and will receive iv dexmedetomidine as 0.5, 0.75,1.0 microgram/Kg bwt just after spinal anesthesia to prevent shivering. Hemodynamic parameters (pulse rate,BP,MAP,SpO2,resp.rate)as well as sedation and shivering,if present, will be noted. 
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