| CTRI Number |
CTRI/2024/09/073968 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To assesss whether Ketamine-Propofol can be replaced by Ketamine-Dexmedetomidine for sedation in surgical excision of breast fibroadenoma |
|
Scientific Title of Study
|
A comparative study to assess the efficacy between Ketamine-Propofol and Ketamine-Dexmedetomidine on sedation in surgical excision of breast fibroadenoma |
| 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 Keerthana R |
| Designation |
Resident ,Department of Anesthesiology |
| Affiliation |
Gulbarga Institute of Medical Sciences |
| Address |
Department of Anesthesiology Gulbarga Institute of Medical Sciences Veeresh Nagar cross Sedam road kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
09886117407 |
| Fax |
|
| Email |
keerthumanjula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Hatti |
| Designation |
Associate professor |
| Affiliation |
Gulbarga Institute of Medical Sciences |
| Address |
Department of Anesthesiology Gulbarga Institute of Medical Sciences Veeresh Nagar cross Sedam road kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9740478820 |
| Fax |
|
| Email |
drrhatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerthana R |
| Designation |
Resident |
| Affiliation |
Gulbarga Institute of Medical Sciences |
| Address |
Gulbarga Institute of Medical Sciences Veeresh nagar sedam road kalaburagi 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
09886117407 |
| Fax |
|
| Email |
keerthumanjula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gulbarga Institute of Medical Sciences Veeresh nagar sedam road kalaburagi 585105 |
|
|
Primary Sponsor
|
| Name |
Gulbarga Institute of Medical Sciences |
| Address |
Gulbarga Institute of Medical Sciences Veeresh nagar sedam road kalaburagi 585105 |
| 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 |
| DrKeerthana R |
Gulbarga Institute of Medical Sciences |
Department of Anesthesiology, Gulbarga Institute of Medical Sciences Veeresh nagar sedam road kalaburagi 585105
Gulbarga
KARNATAKA |
9886117407
keerthumanjula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GULBARGA INSTITUTE OF MEDICAL SCIENCES, KALABURAGI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N602||Fibroadenosis of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KETAMINE - DEXMEDETOMIDINE |
TO STUDY THE EFFICACY OF KETAMINE - DEXMEDETOMIDINE AS SEDATION IN CASES OF FIBROADENOMA KETAMINE AT THE DOSE OF 1-2mg/kg AND DEXMEDETOMIDINE AT THE DOSE OF 1-2 mcg/kg AS INTRAVENOUS DURING THE START OF THE SURGERY AND THE LEVEL OF SEDATION IS ASSESSED BY RAMSAY SEDATION SCORE UNTIL THE SURGERY IS COMPLETED |
| Comparator Agent |
KETAMINE-PROPOFOL |
TO STUDY THE EFFICACY OF KETAMINE-PROPOFOL AS SEDATION IN CASES OF FIBROADENOMA ADMINISTERED IN BOLUS DOSE AT 1-2mg/kg AS INTRAVENOUS DURING THE START OF THE SURGERY THEN USING RAMSAY SEDATION SCORE THE LEVEL OF SEDATION IS ASSESSED UNTIL THE COMPLETION OF SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
adult patient aged from 18 yrs to 60 yrs posted for surgical excision of fibroadenoma and belongs to ASA-1 and ASA-2 those who have given consent |
|
| ExclusionCriteria |
| Details |
adult aged more than 60 years and anticipated difficult airway and those who have allergy to drugs
pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine the efficacy between ketamine-propofol and dexmedetomidine- ketamine on adequate sedation using Ramsay sedation scale |
Ketamine- Propofol is administered during the start of the surgery and using Ramsay sedation scale sedation score is given for every 5mins until the surgery is completed .
For another group patient receiving Ketamine-Dexmedetomidine sedation score is given after this drug administration using Ramsay sedation scale from the start of the surgery to every 5 mins until the surgery is completed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| recovery time from sedation in cases posted for surgical excision of breast fibroadenoma |
recovery time is assessed once the surgery is completed using modified Aldrete score is given every 5 mins upto 30 mins |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/07/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is mainly aiming to study the efficacy of KETAMINE - DEXMEDETOMIDINE versus KETAMINE - PROPOFOL as sedation for fibroadenoma . KETAMINE - PROPOFOL is already established for sedation where as dexmedetomidine is a newly introduced drug . this is the first time comparison of these two drugs groups are being used in sedation for fibroadenoma. Hoping this study will help in switch to newer, much safer drugs |