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
|
|
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
|
|
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) |