| CTRI Number |
CTRI/2026/03/106083 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study Comparing Two Sedative Drugs in Children Undergoing Anaesthesia |
|
Scientific Title of Study
|
Comparative Analysis of Intranasal Midazolam versus Dexmedetomidine as Paediatric Premedication: Impact on Sedation, Anxiolysis, Mask Acceptance, Procedure Response, Hemodynamic Stability, and Postoperative Agitation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Belgaumkar |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sidhartha Medical College |
| Address |
Ground floor, department of Anaesthesiology, Sri Sidhartha Medical College, Tumkur
Second main, first cross, Vijayanagara
Tumkur
KARNATAKA
572107
India |
| Phone |
8762771374 |
| Fax |
|
| Email |
alokbelgaumkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alok Belgaumkar |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sidhartha Medical College |
| Address |
Ground floor, Department of Anaesthesiology, Sri Sidhartha Medical College, Tumkur
Second main, first cross, Vijayanagara
Tumkur
KARNATAKA
572107
India |
| Phone |
8762771374 |
| Fax |
|
| Email |
alokbelgaumkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alok Belgaumkar |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sidhartha Medical College |
| Address |
Ground floor, Department of Anaesthesiology, Sri Sidhartha Medical College, Tumkur
Second main, first cross, Vijayanagara
Tumkur
KARNATAKA
572107
India |
| Phone |
8762771374 |
| Fax |
|
| Email |
alokbelgaumkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alok Belgaumkar |
| Address |
Department of Anaesthesiology, Sri Sidhartha Medical College, Tumkur, Karnataka, India- 572107 |
| Type of Sponsor |
Other [Self-funded ] |
|
|
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 Alok Belgaumkar |
Sri Sidhartha Medical College, Tumkur-07 |
Department of Anaesthesia, Operation theatre complex, ground floor
Tumkur
KARNATAKA |
8762771374
alokbelgaumkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SRI SIDHARTHA MEDICAL COLLEGE |
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 |
Group D: Dexmedetomidine intranasal spray |
1 µg/kg of intranasal dexmedetomidine once 30 minutes before shifting inside the operating room/giving general anaesthesia |
| Intervention |
Group M: Midazolam intranasal spray |
0.2 mg/kg of intranasal midazolam once 30 minutes before shifting inside the operating room/giving general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 4 to 10 years
2. ASA Class I & II patients
3. Undergoing elective surgeries under general anaesthesia
4. Willingness of parent/guardian to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Parent refusal for consent
2. Known allergy or contraindication to midazolam or dexmedetomidine
3. Patients with upper respiratory tract infection or nasal pathology
4. Children with cardiovascular, renal, hepatic, or neurological disorders
5. History of delayed development or psychological disorders
6. Children on sedative or antiepileptic medications
7. Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no significant difference between intranasal midazolam and intranasal dexmedetomidine in terms of sedation quality, anxiolysis, and perioperative cooperation in paediatric patients. |
Baseline (before intranasal drug), 15 minutes and 30 minutes after intranasal premedication in preoperative holding area.” |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/03/2026 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alokbelgaumkar@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 21-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This prospective, randomized, comparative study aims to evaluate and compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam as premedication in paediatric patients aged 4 to 10 years (ASA I to II) undergoing elective surgeries under general anaesthesia. Eighty children will be randomly allocated into two groups Group M intranasal midazolam 0.2 mg per kg and Group D intranasal dexmedetomidine 1 µg per kg, administered 30 minutes before induction. The primary outcome is sedation score assessed at 15 and 30 minutes post-administration. Secondary outcomes include anxiolysis at parental separation, venipuncture response, mask acceptance, postoperative agitation, and hemodynamic parameters HR, BP, SpO2. The study hypothesizes that intranasal dexmedetomidine will provide superior sedation quality and improved procedural cooperation with comparable safety profile compared to midazolam |