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Clinical Trials/CTRI/2025/11/097919
CTRI/2025/11/097919
Not yet recruiting
Not Applicable

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

Department of Anaesthesiology1 site in 1 country100 target enrollmentStarted: December 5, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of Anaesthesiology
Enrollment
100
Locations
1
Primary Endpoint
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.

Overview

Brief Summary

This prospective randomized study aims to compare two dexmedetomidine infusion rates 0.2 and 0.3 micrograms per kilogram per hour for preventing emergence agitation in children aged two to twelve years undergoing general anesthesia One hundred patients will be divided into two equal groups and given standardized anesthesia using volatile agents Emergence agitation and pain will be assessed using clinical scales in the postoperative period The study will compare the incidence severity recovery time and adverse effects including bradycardia hypotension and desaturation to identify the optimal infusion rate that ensures effective prevention of emergence agitation with stable hemodynamic parameters

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
2.00 Year(s) to 12.00 Year(s) (—)
Sex
All

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

  • (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.

Outcomes

Primary Outcomes

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.

Time Frame: Interim Assessments after every 06 months

Secondary Outcomes

  • 1.Comparison of duration of recovery in each group(2. Adverse events in each group)

Investigators

Sponsor
Department of Anaesthesiology
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Harindra Kumar Goje

INHS ASVINI

Study Sites (1)

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