| CTRI Number |
CTRI/2023/04/051844 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparision between intrathecal bupivacaine with fentanyl and bupivacaine with midazolam in lower abdominal and lower limb surgeries |
|
Scientific Title of Study
|
Comparative Study of Intrathecal Bupivacaine With FentanvI and Bupivacaine with Midazolam in Lower Abdominal and Lower Limb Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayant Bhatia |
| Designation |
Junior Resident |
| Affiliation |
Department of anesthesia |
| Address |
Dr D Y Patil Medical College Hospital and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9911766166 |
| Fax |
|
| Email |
jayant.bhatia0314@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChhaya M Suryawanshi |
| Designation |
Hod Professor |
| Affiliation |
Department of anesthesia |
| Address |
Dr DYPatil medical college hospital and research centre Pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChhaya M Suryawanshi |
| Designation |
Hod Professor |
| Affiliation |
Department of anesthesia |
| Address |
Dr DYPatil medical college hospital and research centre Pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy high tech OT 5th floor |
|
|
Primary Sponsor
|
| Name |
Dr Jayant Bhatia |
| Address |
Dr DY Patil medical college hospital and research centre |
| Type of Sponsor |
Other [self] |
|
|
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 Jayant Bhatia |
Dr DY Patil medical college and hospital research centre pimpri pune |
Hi Tech ot 5th floor ot complex dept of anesthesia
Pune
MAHARASHTRA |
9911766166
jayant.bhatia0134@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub committee Dr DY Patil medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRATHECAL BUPIVACAINE AND FENTANYL |
INTRATHECAL BUPIVACAINE 0.5% 3ml WITH FENTANYL 0.5ml 25mcg IN LOWER ABDOMINAL AND LOWER LIMB SURGERIES |
| Comparator Agent |
INTRATHECAL BUPIVACAINE AND MIDAZOLAM |
INTRATHECAL BUPIVACAINE 3ml 0.5% WITH MIDAZOLAM 2.5mg 0.5ml IN LOWER ABDOMINAL AND LOWER LIMB SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II fit patients
Ages between 18 and 60 years
Patients undergoing lower abdominal and lower limb surgeries under spinal anesthesia
Haemodynamically stable patients with all routine investigations within normal limits without any other co morbidities.
Patients who are not on any cardiac related drugs.
Availability of written informed consent from concerned patient |
|
| ExclusionCriteria |
| Details |
Patients not willing to get enrolled in this study
Patients with ASA physical status III or more
Patients below 18 years and above 60 years of age
Patients posted for emergency procedures
Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc
Patients with spine deformities or local skin interactions overlying the lumbar vertebral region
Patients with bleeding or coagulation disorders.
Patients with known allergies to the study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE ONSET OF MOTOR AND SENSORY BLOCK AND DURATION OF ANALEGESIA WITH ADDITION OF MIDAZOLAM OR FENTANYL TO 0.5%BUPIVACAINE HEAVY IN SUB ARACHNOID BLOCK -baseline, 5min 10 min 15 min 20 min 30 min 45 min 60 min |
baseline,
5min ,
10 min,
15 min,
20 min,
30 min,
45 min,
60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA |
TO MONITOR HEART RATE SP02 AT 0MIN 5 MIN 10 MIN 15 MIN 30 MIN |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
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 - Proposals should be directed to [jayant.bhatia0134@gmail.com].
- For how long will this data be available start date provided 26-02-2024 and end date provided 26-12-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
IT IS A PROSPECTIVE COMPARATIVE RANDOMISED DOUBLE BLINDED STUDY WHERE IN INTRATHECAL BUPIVACAINE WITH FENTANYL AND INTRATHECAL BUPOVACAINE WITH MIDAZOLAM ARE COMPARED FOR ONSET QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL AND LOWER LIMB SURGERIES |