| CTRI Number |
CTRI/2024/03/063804 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effects of nasal dexmedetomidine and midazolam before operation in children |
|
Scientific Title of Study
|
Comparative study between nasal atomized dexmedetomidine and midazolam as premedication in children |
| Trial Acronym |
na |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Department Of Anesthesia and Critical Care PGIMS Rohtak |
| Address |
Room No. 5 Department of Anesthesia PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Susheel Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department of Anesthesia PGIMS Rohtak |
| Address |
Department of Anesthesia PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708896174 |
| Fax |
|
| Email |
susheelchhoker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susheel Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department of Anesthesia PGIMS Rohtak |
| Address |
Department of Anesthesia PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708896174 |
| Fax |
|
| Email |
susheelchhoker@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma University of Health Sciences Rohtak |
| Address |
Room No 5 Department of Anaesthesia and critical care PGIMS Rohtak |
| 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 |
| Dr Susheel Kumar |
PGIMS Rohtak |
Room no 5 Department of Anaesthesia and critical care
Rohtak
HARYANA |
8708896174
susheelchhoker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal atomized dexmedetomidine |
Administration of atomized dexmedetomidine intranasally attached to a syringe of 1ml at a dose of 1.0 ug/Kg with the drug taken from the ampule of 100 ug/ml for premedication in children in age group between 2 to 8 years |
| Intervention |
Intranasal atomized midazolam |
Administration of atomized midazolam intranasally attached to a syringe of 1ml at a dose of 0.2 mg/Kg with the drug taken from the ampule of 5mg/ml for premedication in children in age group between 2 to 8 years |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children belonging to either sex age between 2 t0 8 year with ASA physical status 1 and 11 scheduled to undergo various elective surgical procedures |
|
| ExclusionCriteria |
| Details |
1 children with systemic illness
2 parent refusal
3 known allergic to midazolam and dexmedetomidine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparative study between intranasal atomized midazolam and dexmedetomidine |
outcome will be accessed after 30 minute of drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 sedation score
2 parent separation
3 mass acceptance |
accessed after 30 minute of drug administration |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="0"
Months="0"
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
|
Both midazolam and dexmedotomidine are being used for premedication in children undergoing various surgeries.These drugs will help in reducing anxiety and provide analgesia and better outcome after the surgery. |