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CTRI Number  CTRI/2020/05/025233 [Registered on: 18/05/2020] Trial Registered Prospectively
Last Modified On: 15/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see the additive epidural analgesic effect of two drugs dexmedetomidine & fentanyl 
Scientific Title of Study   An observational study between Fentanyl v/s Dexmedetomidine as adjuvant to epidural ropivacaine for postoperative analgesia in spine surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rupak Kumar 
Designation  Post graduate student 
Affiliation  Department of Anaesthesiology Ptjnm medical college raipur 
Address  Department of Anaesthesiology, Pt. J.N.M. Medical College,Raipur.
Department of Anaesthesiology DKS Superspeciality Research center Raipur
Raipur
CHHATTISGARH
491002
India 
Phone  08516035046  
Fax    
Email  Dr.rupak2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Singh 
Designation  Associate professor 
Affiliation  Ptjnm medical college raipur 
Address  Department of Anaesthesiology & Critical care Pt.JNM medical College Raipur
Raipur
Raipur
CHHATTISGARH
492005
India 
Phone  9684666444  
Fax    
Email  Drdeepakaims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rupak Kumar 
Designation  Post graduate student 
Affiliation  Department of anesthesiologyPtjnm medical college raipur 
Address  Department of Anaesthesiology Ptjnm medical CollegeRaipur
S/2,D/14, vasundhara vihar, Ambikapur,Surguja,c.g.
Raipur
CHHATTISGARH
491002
India 
Phone  08516035046  
Fax    
Email  Dr.rupak2010@gmail.com  
 
Source of Monetary or Material Support  
DKS Superspeciality Research center Raipur chhattisgarh. 
 
Primary Sponsor  
Name  Ptjnm medical college 
Address  Raipur 
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 
DRCPBHAGAT  PTJNM Medical college   Department of Anaesthesiology & critical care room no. 315
Raipur
CHHATTISGARH 
9575799345

cpbhagat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G890||Central pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl v/s Dexmedetomidine  Fentanyl1mcg/ml with Ropivacaine 0.125%@ v/s dexmedetomidine 1mcg/ml with Ropivacaine 0.125%@ in epidural space as continuous infusion to be titrated. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing lower thoracic (below T8)& lumbosacral spine fixation 
 
ExclusionCriteria 
Details  1.Refuse to participate, 2.chronic pain syndrome, 3. cardiac diseases,4.hematological disease, 5.psychiatric disease,6.allergy to local anaesthetic, 7.upper thoracic & 8.cervical spine surgery,9.tubercular spine 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Analgesia using VISUAL ANALOG SCORE.  1year 
 
Secondary Outcome  
Outcome  TimePoints 
Patients satisfaction
Ramsay sedation score
Heart rate
Blood pressure
Side effects 
24 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   18/05/2020 
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="0"
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)?  

Brief Summary   A comparative interventionals study between fentanyl & dexmedetomidine as adjuvant (enhancement of duration of sensory block or analgesia with lower degree of motor block) epidural Ropivacainefor post operative analgesia in spine surgery (Lumbar laminectomy)  
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