| CTRI Number |
CTRI/2018/02/012149 [Registered on: 26/02/2018] Trial Registered Prospectively |
| Last Modified On: |
12/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled 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 orthopedic 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 |
| 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,IGIMS PATNA
DEPARTMENT OF ANAESTHESIOLOGY,INDIRA GANDHI
INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA.
Patna
BIHAR
800014
INDIA
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 ANAESTHESIOLOGY,INDIRA GANDHI
INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA.
BIHAR
800014
India
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 ANAESTHESIOLOGY,INDIRA GANDHI
INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA.
BIHAR
800014
India
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 ,PATNA |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY IGIMS PATNA BIHAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA. Patna BIHAR 800014 India
DEPARTMENT OF ANAESTHESIOLOGY,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA. Patna 800014 BIHAR 800014 India
Patna
BIHAR
800014
India |
| 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,IGIMS
Patna
BIHAR
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 |
| Patients |
1.AMERICAN SOCIATY OF ANESTHESIOLOGIST GRADE 1 & 2
2.Age group 18-60 years of either sex
3.Patients giving valid informed consent
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal bupivacaine and intrathecal fentanyl |
3ml (0.5%)bupivacaine
0.5 ml (25mcg)fentanyl |
| Comparator Agent |
Intrathecal bupivacaine and intrathecal magnesium sulphate |
3ml (0.5%) bupivacaine and
0.1 ml magnesium sulphate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and 2 patients
2.Age group 18-60 years of either sex
3.Patients giving valid informed consent
4.Height 150-180cm and those undering 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 analgesic effect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nausea,Vomitting,Hypotension,Bradycardia,Respiratory depression,Pruritus,Urinary retention,maximum sedation score |
1 min,5 min,10 min,15 min,20 min,25 min, 30 min,35 min,40 min,45 min, 50 min, 55 min, 60 min |
|
|
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)
|
06/03/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Comperative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb orthopaedic surgery |