| 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
|