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Comparison of two ways of giving sedation medicine in children via nasal and intravenous route for safety in general anaesthesia

To assess the effect of Intranasal and Intravenous Dexmedetomidine for sedation in paediatric patients undergoing general anaesthesia - PAED DEX Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109607
Enrollment
60
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R688- Other general symptoms and signs

Interventions

Intervention1: Dexmedetomidine during general anaesthesia: Study to assess the effect of intranasal and intravenous Dexmedetomidine for sedation in paediatric patients undergoing General Anaesthesia

Sponsors

Gandhi medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Either sex of age 4 - 10 years undergoing elective paediatric surgeries ASA Grade I and II

Exclusion criteria

Exclusion criteria: Patients with major congenital anomalies coagulation abnormalities/ Bleeding Diathesis ASA Grade III and above Patients having a history of significant neurological, psychiatric or neuromuscular disorders Any cardiac disease History of allergic reactions

Design outcomes

Primary

MeasureTime frame
To compare onset of sedation depth of sedation by Ramsay sedation score To evaluate parents and patient satisfaction by Parental separation scale To evaluate mask acceptance and ease of administration scoreTimepoint: Every 5 minutes after drug administration till the Ramsay sedation score is achieved 2 or more

Secondary

MeasureTime frame
To evaluate hemodynamic stability and adverse effects associated with both routesTimepoint: Vitals- HR, RR, SpO2 Pre procedure vitals At time of drug administration 10 minutes after drug administration At time of shifting to OT OT Baseline At time of induction Every 15 minutes after induction At extubation Vitals at time of shifting out of OT Every 15 minutes for 60 minutes Every 30 minutes till 120 minutes Adverse effects if any

Countries

India

Contacts

Public ContactDr Sonal Awasya

Gandhi medical college and associated Hamidia Hospital Bhopal

awasya.84@gmail.com9200314936

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026