| CTRI Number |
CTRI/2024/11/076533 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of iv midazolam and fentanyl and iv midazolam and butrum for MRI sedation |
|
Scientific Title of Study
|
To Compare Effect Of Intravenous Injection Fentanyl With Injection Midazolam And Injection Buterophenol With Injection midazolam In MRI Sedation In Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janhavi Dahake |
| Designation |
Junior resisdent |
| Affiliation |
Datta meghe institute of medical science and research |
| Address |
Department of Anesthesia,
second floor,
Acharya Vinobha Bhave Hospital.
Department of Anesthesia,
Datta meghe institute of health science and research
Wardha
MAHARASHTRA
442302
India |
| Phone |
09922155413 |
| Fax |
|
| Email |
janhavidahake98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta verma |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of medical science and research |
| Address |
Department of Anesthesia,
second floor,
Acharya Vinobha Bhave Hospital.
Department of Anesthesia,
second floor,
Acharya Vinobha Bhave Hospital.
Wardha
MAHARASHTRA
442302
India |
| Phone |
09922155413 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janhavi Dahake |
| Designation |
Junior resisdent |
| Affiliation |
Datta meghe institute of medical science and research |
| Address |
Department of Anesthesia,
second floor,
Acharya Vinobha Bhave Hospital.
Department of Anesthesia,
Datta meghe institute of health science and research
Wardha
MAHARASHTRA
442302
India |
| Phone |
09922155413 |
| Fax |
|
| Email |
janhavidahake98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Sawangi Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NA |
| NIL |
NA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janhavi Dahake |
Acharya Vinoba Bhave Rural Hospital |
Dept of Anesthesia, 2nd floor, SMSC Building, Sawangi Meghe 442001
Wardha
MAHARASHTRA |
09922155413
janhavidahake98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Sawangi Wardha India 442001 |
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 |
| Comparator Agent |
Inj. Midazolam and inj. Butrum |
Sedative drugs used for sedation in patients for MRI.
Injection Midazolam 0.05 mg/kg
Injection butrum 1 added with it. given for around 30 mins duration. |
| Intervention |
Injection Midazolam with Injection Fentanyl |
Injection Midazolam (0.05 mg/kg)with Injection Fentanyl(0.01 mg/kg) will be administered in patients for sedation during MRI for 30 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA-1 and ASA-2 Patients
2.Patients uncooperative without sedation.
3.Patients having age between 18-65years
4.Nil by mouth atleast for 2 hours before sedation
|
|
| ExclusionCriteria |
| Details |
• ASA-3 and ASA-4 patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Injection Midazolam and Injection Fentanyl is better for MRI sedation. Availability of drug and better effect of sedation using drug is observed. hemodynamic vitals are noted |
study duration for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
MRI sedation is very commonly used both in adults and pediatric population. IV sedation is preferred, drugs used are iv midazolam along with fentanyl and butrum. butrum is easily available, easy to use and good effect . the short study above will compare both the drugs two groups are formed and effects are compared,
|