| CTRI Number |
CTRI/2017/08/009281 [Registered on: 07/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the drug useful in increasing the efficacy of spinal anesthesia |
|
Scientific Title of Study
|
Comparison of intrathecal Dexmedetomidine and Buprenorphine as adjuvant to Bupivacaine for lower limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Colaco Rohan John F R H |
| Designation |
post graduate in anesthesia |
| Affiliation |
Father Muller Medical College |
| Address |
Father muller medical boys hostel
Room number 501
Father Muller hospital
PostGraduate in department of Anesthesia
kankanady mangalore
Father muller medical boys hostel
Room number 501
Father muller hospital
PostGraduate in department of Anesthesia
kankanady mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8497097168 |
| Fax |
|
| Email |
rohan.20041991.08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurumurthy |
| Designation |
MD anesthesia associate professor |
| Affiliation |
Father Muller Medical College |
| Address |
606 Father Muller boys hostel
Associate professor in department of Anesthesia
Father muller hospital
Kankanady Mangalore
606 Father Muller boys hostel
Associate professor in department of Anesthesia
Father muller hospital
Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9448026663 |
| Fax |
|
| Email |
drgurumurthy@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Colaco Rohan John F R H |
| Designation |
post graduate in anesthesia |
| Affiliation |
Father Muller Medical College |
| Address |
Father muller medical boys hostel
Room number 501
PostGraduate in department of Anesthesia
Father Muller hospital
kankanady Mangalore
Father muller medical boys hostel
Room number 501
Post Graduate in department of Anesthesia
Father Muller hospital
kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8497097168 |
| Fax |
|
| Email |
rohan.20041991.08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College
kankanady Mangalore 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller hospital |
| Address |
Father Muller hospital Kankanady Mangalore 575002 |
| Type of Sponsor |
Private 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 |
| DR Colaco Rohan John F R H |
Father Muller hospital |
Father muller medical boys hostel
Room number 501
PostGraduate in department of Anesthesia
kankanady mangalore 575002
Dakshina Kannada
KARNATAKA |
8497097168
Rohan.20041991.08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father muller institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Posted for elective surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine 0.5% 2.5ml intrathecal once |
local anesthetic used for spinal anesthesia |
| Comparator Agent |
Buprenorphine 60mcg plus bupivacaine 0.5% (h) 2.5ml via intrathecal once |
Mixed agonist and antagonist |
| Comparator Agent |
Dexmedetomidine 5mcg plus 0.5% bupivacaine (h) 2.5mlvia intrathecal once |
Selective alpha 2 agonist |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between age 15-65yrs undergoing elective surgery .
2 ASA class I and 2.
|
|
| ExclusionCriteria |
| Details |
1 Patients with cardiac disease, heart block, dysarrythmia, beta blockers and alpha antagonist 2 ASA class 3 and 4.
3 Patients not wiling for spinal anaesthesia.
4 Allergy to drugs.
5 History of drug abuse, space occupying lesion, bleeding disorders.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check which drug has better outcome as adjuvants to intrathecal Bupivacaine |
FOR A PERIOD OF 2 YEARS
June 2018
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor its effect on post operative pain relief |
For a period of 2 years
june 2018 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/10/2016 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anesthesia is widely used anesthesia. It is beneficial, cheap. Many studies are done to increase the efficacy of spinal anestheia. Buprenorphine and Dexmedetomidine are used as adjuvants for such purpose. Objective is to compare the efficacy of these two drugs when used as adjuvants to intrathecal Bupivacaine |