| CTRI Number |
CTRI/2025/06/088010 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intranasal alpha-2 agonists for premedication in paediatric patients undergoing surgery |
|
Scientific Title of Study
|
Intranasal dexmedetomedine for premedication in paediatric patients undergoing surgery under general anaesthesia |
| 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 Sarakam Sreelakshmi |
| Designation |
MD Anaesthesia |
| Affiliation |
Gayatri vidya parishad institute of health care and medical technology |
| Address |
Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
8074921898 |
| Fax |
08912590131 |
| Email |
sarakamsreelakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Owk Mrunalini |
| Designation |
MD anaesthesia |
| Affiliation |
Gayatri vidya parishad institute of health care and medical technology |
| Address |
Gayatri Vidya Parishad Institute Of Health Care and Medical Technology,Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
8897234462 |
| Fax |
08912590131 |
| Email |
owkmrunalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Owk Mrunalini |
| Designation |
MD Anaesthesia |
| Affiliation |
Gayatri vidya parishad institute of health care and medical technology |
| Address |
Room no 26,Gayatri Vidya Parishad Institute Of Health Care and Medical Technology,Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
8897234462 |
| Fax |
08912590131 |
| Email |
owkmrunalini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gayatri Vidya Parishad Institute Of Health Care and Medical Technology,Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048 |
|
|
Primary Sponsor
|
| Name |
Gayatri Vidya Parishad Institute Of Health Care and Medical Technology |
| Address |
Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048 |
| Type of Sponsor |
Private 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 Manjula V ramsali |
Gayatri Vidya Parishad Institute Of Health Care and Medical Technology |
Department of Anaesthesiology,6-25,Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048
Visakhapatnam
ANDHRA PRADESH |
9989335429
08912590131
manjularamsali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee GVPIHCMT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H660||Acute suppurative otitis media, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal dexmedetomedine
|
Intranasal dexmedetomedine 1.5mcg/kg for premedication 60mins before undergoing planned surgery under general anaesthesia
|
| Intervention |
Intranasal dexmedetomedine
|
Intranasal dexmedetomedine 1mcg/kg for premedication 60mins before undergoing planned surgery under general anaesthesia
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients coming for elective surgery under general anaesthesia.
Age between 1 to 12 years both sexes
ASA 1 and ASA 2. |
|
| ExclusionCriteria |
| Details |
Parental refusal for consent
ASA grade 3 and higher.
Paediatric patients with cardiac problems |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The sedative effects on the child in the pre operative period and while
shifting to OT |
20mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pre op, Intra op, post op haemodynamics and saturation.
Behaviour and Wake up behavioural score.
Behaviour of the child in the pre operative period and while shifting to OT |
15mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins |
|
|
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)
|
14/07/2025 |
| 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="0"
Months="6"
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 interventional study is to compare the efficacy and safety of the two different doses of intranasal dexmedetomidine 1mcg/kg and 1.5mcg/kg as a premedication in the paediatric patients undergoing elective surgeries under general anaesthesia. |