NCT07268924

The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.

Detailed description

Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation . Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery. Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA . Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA. So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?

Conditions

• Emergence Delirium, Anesthesia

Interventions

Type	Name	Description
DRUG	Propofol	In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus
DRUG	Lidocaine %2 ampoule	In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Egypt