| CTRI Number |
CTRI/2020/12/030095 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Dexmeditomidine, Fentanyl as an adjuvant to Bupivacaine for Unilateral spinal anaesthesia in lower limb surgery. |
|
Scientific Title of Study
|
Comparison of Bupivacaine-Dexmedetomidine vs Bupivacaine-Fentanyl vs Bupivacaine -Saline for Unilateral spinal anaesthesia in lower limb surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun George |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SSG HOSPITAL |
| Address |
DEPT OF ANESTHESIOLOGY
SSG HOSPITAL
KALA GODA CIRCLE
SAYAJIGUNJ
BARODA,GUJARAT
13 B Eastern cooperative housing society
Opp Emperor building
Fatehgunj,Vadodara,Gujarat
Vadodara
GUJARAT
390002
India |
| Phone |
09947488928 |
| Fax |
|
| Email |
arungeorgette@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAMTA G PATEL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY |
| Address |
DEPT OF ANESTHESIOLOGY
SSG HOSPITAL
KALA GODA CIRCLE
SAYAJIGUNJ
BARODA,GUJARAT
DEPT OF ANESTHESIOLOGY
SSG HOSPITAL
KALA GODA CIRCLE
SAYAJIGUNJ
BARODA,GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA G PATEL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY |
| Address |
SSG HOSPITAL
KALA GODA CIRCLE
SAYAJIGUNJ
BARODA,GUJARAT
SSG HOSPITAL
KALA GODA CIRCLE
SAYAJIGUNJ
BARODA,GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
|
| Email |
mgpatel111@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SSG HOSPITAL |
| Address |
SSG HOSPITAL
NEAR KALA GODA CIRCLE
VADODARA,GUJARAT,390001 |
| 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 |
| ARUN GEORGE A |
GOVERNMENT MEDICAL COLLEGE AND SSG HOSPITAL, VADODARA |
DEPARTMENT OF ANESTHESIOLOGY SSG HOSPITAL
NEAR KALA GODA CIRCLE
VADODARA,GUJARAT
Vadodara
GUJARAT |
9947488928
arungeorgette@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine-Dexmedetomidine |
Inj 0.5%Bupivacaine 1ml+Inj Dexmedetomidine 5mcg given intrathecally once before procedure |
| Intervention |
Bupivacaine-Fentanyl |
Inj 0.5% Bupivacaine 1ml +Inj Fentanyl 25 mcg given intrathecally once before procedure |
| Comparator Agent |
Bupivacaine-Saline |
Inj 0.5% Bupivacaine 1ml+Inj Saline 0.5ml given intrathecally once before procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for lower limb surgeries of one side |
|
| ExclusionCriteria |
| Details |
Patient refusal
Local site infection
Coagulopathy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of sensory block,
Maximum duration of sensory block,
Onset of motor block,
Maximum duration of motor block . |
Onset of sensory block- 1,5,10,15,30,45,60,90,120 minutes
Onset of motor block-1,5,10,15,30,60,90,120 minutes
Maximum duration of motor block-1,5,10,15,30,60,90,120 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia |
Duration of post operative analgesia till 240mins |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/01/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included arungeorgette@yahoo.com ).
- For how long will this data be available start date provided 01-06-2021 and end date provided 31-12-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Comparison of Bupivacaine-Dexmdetomidine vsBupivacaine-Fentanyl vs Bupivacaine -Saline for Unilateral spinal anesthesia in lower limb surgery Unilateral spinal anesthesia is a safe and simple procedure for surgeries of lower limb of one side. The aim of the current study is to compare the effects of adding Dexmedetomidine, Fentanyl and Saline to low dose 1ml(5mg) hyperbaric bupivacaine on the sensory and motor characteristics of unilateral spinal anesthesia in patients undergoing lower limb surgery. |