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NOT YET RECRUITING
NCT07871266
PHASE3

Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and irritation in the upper airway. The primary aim of this clinical trial is to evaluate whether preoperative administration of nebulized lidocaine reduces the incidence and severity of emergence agitation compared to normal saline in pediatric patients undergoing elective tonsillectomy under sevoflurane anesthesia. Participants are randomly allocated into two study groups in a 1:1 ratio: * Group A (Lidocaine Group): Receives preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to 4 mL) administered via a nebulizer. * Group B (Control Group): Receives preoperative inhalation of an identical volume (4 mL) of 0.9% normal saline placebo via a nebulizer. Both groups receive a standardized sevoflurane-based general anesthetic. Emergence agitation is evaluated during the first 30 minutes following anesthesia cessation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes evaluate postoperative pain severity (FLACC scale), rescue analgesic and sedative requirements, time to extubation, PACU length of stay, and airway-related or systemic complications.

Official title: Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy: A Randomized Controlled Double-Blinded Clinical Trial

Key Details

Gender

All

Age Range

3 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-11

Completion Date

2027-12

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Lidocaine

Preoperative administration of 2% preservative-free lidocaine at a dose of 2 to 4 mg/kg, diluted to a total volume of 4 mL, delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.

DRUG

0.9% Normal Saline

Preoperative administration of an identical volume of 4 mL of 0.9% normal saline delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.