Effect of Dexmedetomidine on Sevoflurane-Induced Emergence Agitation in Children Undergoing Surgery

A prospective randomised double blind study to evaluate the effect of Dexmedetomidine on Sevoflurane induced Emergence Agitation in children undergoing surgery. - NILL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110434

Enrollment

Registered

2026-05-12

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: O- Medical and Surgical Health Condition 2: R451- Restlessness and agitation

Interventions

Intervention1: Dexmedetomidine: Intravenous (IV) administration of Dexmedetomidine 0.3 mcg/kg diluted in 10 mL Normal Saline, given over 2 3 minutes, 5 minutes before the end of surgery Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: Children 2 to 10 years of age. ASA PS grade I & II risk status Parents giving informed written consent. Patients undergoing elective surgeries under sevoflurane anaesthesia.

Exclusion criteria

Exclusion criteria: Patient with hypersensitivity to dexmedetomidine Patient with pre-existing anatomical cardiac defects. Patients with facial and upper respiratory tract anatomical defects

Design outcomes

Primary

Measure	Time frame
Incidence and severity of Incidence and severity of Emergence Agitation (EA) following Sevoflurane anesthesia in children, measured using Aonos Four-Point Scale and PAED Scale.Timepoint: PACU admission (T0), 5 min (T5), 15 min (T15), and 30 min (T30) post-extubation.	—

Secondary

Measure	Time frame
Time to extubation (from Sevoflurane discontinuation to removal of endotracheal tube). Time to emergence from anesthesia (from Sevoflurane discontinuation to first response to a verbal command). Duration of stay in PACU (total time before meeting discharge criteria). Hemodynamic parameters (Heart Rate, Blood Pressure, Oxygen Saturation) measured at baseline, intra-op, T0, T5, T15, and T30 post-extubation. Incidence of adverse effects (bradycardia, hypotension, sedation, nausea, respiratory depression) monitored throughout the PACU stay.Timepoint: PACU admission (T0), 5 min (T5), 15 min (T15), and 30 min (T30) post-extubation	—

Measure

Time frame

Time to extubation (from Sevoflurane discontinuation to removal of endotracheal tube). Time to emergence from anesthesia (from Sevoflurane discontinuation to first response to a verbal command). Duration of stay in PACU (total time before meeting discharge criteria). Hemodynamic parameters (Heart Rate, Blood Pressure, Oxygen Saturation) measured at baseline, intra-op, T0, T5, T15, and T30 post-extubation. Incidence of adverse effects (bradycardia, hypotension, sedation, nausea, respiratory depression) monitored throughout the PACU stay.Timepoint: PACU admission (T0), 5 min (T5), 15 min (T15), and 30 min (T30) post-extubation

—

Countries

India

Contacts

Public ContactDr Chandan Samaddar

D Y Patil Hospital and Research Centre

anumalliwal@hotmail.com9920318482

Outcome results

None listed

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