CTRI Number |
CTRI/2018/02/012114 [Registered on: 23/02/2018] Trial Registered Prospectively |
Last Modified On: |
22/02/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb surgery |
Scientific Title of Study
|
Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to bupivacaine in spinal anesthesia for patients undergoing lower limb orthopedic surgery:A randomized double blind clinical study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Neha Kumari |
Designation |
Junior Resident |
Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
Address |
Room no-15,1st Floor,New MDH,
Indira Gandhi Institute of Medical Sciences,Patna,Bihar
Patna BIHAR 800014 India |
Phone |
9031007248 |
Fax |
|
Email |
nehascarlet@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ajit Gupta |
Designation |
Professor |
Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
Address |
Department of Anesthesiology,
Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,BIHAR
Patna BIHAR 800014 India |
Phone |
9473191810 |
Fax |
|
Email |
ajpta_igims@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
Dr Ajit Gupta |
Designation |
Professor |
Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA |
Address |
Department of Anesthesiology,
Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna,BIHAR
Patna BIHAR 800014 India |
Phone |
9473191810 |
Fax |
|
Email |
ajpta_igims@yahoo.co.uk |
|
Source of Monetary or Material Support
|
Indira Gandhi Institute of Medical Sciences |
|
Primary Sponsor
|
Name |
Neha Kumari |
Address |
Room no-15,1st Floor,New MDH,
Indira Gandhi Institute of Medical Sciences,PATNA |
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 |
NEHA KUMARI |
Indira Gandhi Institute of Medical Sciences,Sheikhpura,PATNA-14 |
OT complex,first floor,Indira Gandhi Institute of Medical Sciences,Patna Patna BIHAR |
9031007248
nehascarlet@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Indira Gandhi Institute of Medical Sciences,Sheikhpura,PATNA-14 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
1.ASA grade 1 and 2 patients
2.Age group 18-60 yrs of either sex |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Intrathecal bupivacaine and intrathecal fentanyl |
3ml(0.5%)Bupivacaine and 0.5ml(25mcg)fentanyl |
Intervention |
Intrathecal bupivacaine and intrathecal magnesium sulphate |
3ml(0.5%) Bupivacaine and 0.1ml magnesium sulphate |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.ASA group 1 & 2 patients
2.Patients giving valid informed consent
3.Height 150-180cm and those undergoing lower limb orthopedic surgery |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Post-operative analgesic effect |
Post-operative |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nausea,Vomitting,Hypotension,Bradycardia,Respiratory depression,Pruritus,Urinary retention,Maximum sedation score |
1min,5min,10min,15min,20min,25min,30min,35min,40min,45min,50min,55min,60min |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
22/03/2018 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Plan to publish after completion
of the study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb orthopedic surgery |