| CTRI Number |
CTRI/2021/08/035767 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of intrathecal bupivacaine plus dexmedetomidine vs intrathecal bupivacaine plus clonidine for prolongation of analgesia in lower limb orthopedic surgeries |
|
Scientific Title of Study
|
"comparision of itrathecal dexmedetomidine and clonidine as an adjuvant to bupivacaine for lower limb surgeries : A A randomized double blind study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trilok Singh Netam |
| Designation |
PG student |
| Affiliation |
Pt. J.N.M.Medical college Raipur |
| Address |
Department of Anaesthesiology , Pt. J.N.M. Medical college Raipur (C.G.)
Department of Anaesthesiology ,Pt. J.N.M Medical College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098150317 |
| Fax |
|
| Email |
triloktrilok87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K K Sahare |
| Designation |
director professor and HOD |
| Affiliation |
Pt. J.N.M.Medical college Raipur |
| Address |
Department of Anaesthesiology , Pt. J.N.M. Medical college Raipur (C.G.)
Department of Anaesthesiology ,Pt. J.N.M Medical College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9425206894 |
| Fax |
|
| Email |
kamalsahare62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trilok Singh Netam |
| Designation |
PG student |
| Affiliation |
Pt. J.N.M.Medical college Raipur |
| Address |
Department of Anaesthesiology , Pt. J.N.M. Medical college Raipur (C.G.)
Department of Anaesthesiology ,Pt. J.N.M Medical College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098150317 |
| Fax |
|
| Email |
triloktrilok87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Bhimrao Ambedkar Memorial Hospital ,Raipur |
|
|
Primary Sponsor
|
| Name |
DrKK Sahare |
| Address |
Department of Anaesthesiology , Pt. J.N.M. Medical College ,Raipur (C.G,) |
| Type of Sponsor |
Other [] |
|
|
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 Trilok Singh Netam |
Dr. Bhimrao Ambedkar memorial hospital , Raipur |
dept. of Anaesthesia & Critical care Pt. J.N.M. Medical College Raipur
Raipur
CHHATTISGARH |
9098150317
triloktrilok87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE ,Pt. J.N.M.Medical college Raipur (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V99||Unspecified transport accident, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Clonidine 50 mcg with inj bupivacaine 15 mg |
inj. clonidine 50 mcg will be given as an adjuvant to bupivacaine (15 mg) for prolongation of analgesia in subarachnoid block |
| Intervention |
Inj Dexmedetomidine 5 mcg with inj bupivacaine 15 mg |
inj. dexmedetomidine 5 mcg will be given as an adjuvant to bupivacaine(15 mg) for prolongation of analgesia in sub arachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I & II
2.Scheduled for traumatic lower limb orthopedic surgeries under subarachnoid block |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Uncontrolled hypertension
3.Allergy to any drug
4.Cardiac,Respiratory and Neurological dysfunction
5.Sedative drugs consumption
6.Any contraindication for subarachnoid block
7.Height of block above T8
8.Tumor and vascular surgeries of lower limbs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
|
Every 5 minute up to 30 minute and then every 15 minute till completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS score
2.patient satisfaction
3.onset of sensory and motor block
4.duration of sensory and motor block
5.side effect and complication |
Every 5 minute up to 30 minute and then every 15 minute till completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
23/08/2021 |
| 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="0"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
this study is a comparative , interventional study to compare the analgesic effect of two drugs ,clonidine and dexmedetomidine as an adjuvant to bupivacaine for lower limb surgeries in 50 patients in age group 18 to 60 years with ASA physical status II it will be conducted single center in India . the primary outcome will be duration of analgesia and the secondary outcomes will be VAS score ,patient satisfaction ,onset of sensory and motor block ,duration of sensory and motor block, side effects and complication |