| CTRI Number |
CTRI/2024/07/070471 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare Intranasal Dexmedetomidine And Intranasal Midazolam As Premedication In Paediatrics Patients Posted For Day Care Surgery |
|
Scientific Title of Study
|
Comparison Of Intranasal Dexmedetomidine Versus Intranasal Midazolam As Premedication In Paediatrcis Patients Posted For Day Care Surgery. A Randomised Double Blinded Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOHIL S |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8848227595 |
| Fax |
|
| Email |
sohilsaseendran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
FARAH NASREEN |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897067670 |
| Fax |
|
| Email |
kazmifarah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
FARAH NASREEN |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897067670 |
| Fax |
|
| Email |
kazmifarah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim University, ALIGARH |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology And Critical care Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University |
| 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 Sohil S |
JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, UP |
Department of Anaesthesiology And Critical Care, Surgical OT, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
8848227595
sohilsaseendran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine |
Intranasal Dexmedetomidine 2micrograms/kg drug diluted with 0.9% normal saline to total volume of 2ml for one group |
| Comparator Agent |
Intranasal Midazolam |
Intranasal Midazolam 0.2milligrams/kg diluted with 0.9% normal saline diluted to total volume of 2ml |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1 informed consent from parents or guardians
2 ASA grade I and II
3 patients undergoing paediatric day care surgery |
|
| ExclusionCriteria |
| Details |
1 patients having an upper respiratory tract infection
2 Emergency cases
3 known allergies to study drugs
4 significant organ dysfunction
5 congenital disorders
6 more than eighty five percentile of body mass index for age percentiles |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental separation anxiety scale |
30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ramsay sedation scale |
30 mins |
| Mask acceptance scale |
30 mins |
| WATCHA scale of emergence delirium |
30 mins |
| Hemodynamic parameters |
Zero min,5,10,15,20,30, min and 1 hour |
| duration of hospital stay |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2024 |
| 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)
|
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
|
A comparison of intranasal Dexmedetomidine versus intranasal Midazolam as premedication in paediatrics patients posted for day care surgery , a randomized double-blinded study. Done using mucosal atomization device . The primary objective is to assess parenteral separation anxiety using the PSAS scale. A total of 102 patients aged between one and seven years were taken. One group will receive intranasal Dexmedetomidine 2mcg/kg drug diluted with 0.9% normal saline to the total volume of 2ml. The other group will get intranasal midazolam 0.2mg/kg diluted with 0.9 % normal saline to the total volume of 2 ml. Simple random sampling will be done. the primary outcome will assessed based on the parenteral separation anxiety scale. |