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A Study to compare two different doses of dexmedetomidine to find out which is better in preventing restlessness in children after surgery under General Anaesthesia

Comparison of effect of two different Dexmedetomidine infusion rates on emergence agitation in paediatric surgical patients receiving general anaesthesia with volatile anaesthetic agents - CODE-PEA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097919
Enrollment
100
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: Comparison of effect of two different Dexmedetomidine infusion rates on emergence agitation in paediatric surgical patients receiving general anaesthesia with volatile

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (i) Age group 2 to 12 years (ii) Both male and female patients (iii) ASA grade I to II (iv) Undergoing elective surgery in GA

Exclusion criteria

Exclusion criteria: (i) Patients or Parents refusal to consent for the study (ii) Patient with Respiratory and cardiac Diseases (iii) Delayed Milestones (iv) Patient with psychiatric disease (v) ASA Grade III and above (vi) Emergency surgery under GA

Design outcomes

Primary

MeasureTime frame
The study aims to provide evidence on whether a lower infusion rate (0.2 mcg/kg/hr) is as effective as a slightly higher rate (0.3 mcg/kg/hr) in preventing EA, while minimizing hemodynamic instability. The results could guide pediatric anesthesia practice by optimizing dexmedetomidine dosing protocols, improving patient safety, enhancing recovery profiles and reducing perioperative complications related to EA.Timepoint: Interim Assessments after every 06 months

Secondary

MeasureTime frame
1.Comparison of duration of recovery in each group 2. Adverse events in each groupTimepoint: Interim Assessments after every 06 months

Countries

India

Contacts

Public ContactDr Devunuri Naresh

INHS ASVINI

anoopsharma.afmc@gmail.com8369847544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026