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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07268924
Enrollment
82
Registered
2025-12-08
Start date
2026-01-31
Completion date
2027-12-31
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

Emergence Delirium, Anesthesia

Keywords

Emergence agitation in anesthesia

Brief 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 ?

Interventions

DRUGPropofol

In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus

In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

* Elective tonsillectomy operation * pediaterics between ( 4 : 7 ) years old * ASA I OR II

Exclusion criteria

* emergency cases as bleeding tonsills * ASA III OR IV

Design outcomes

Primary

MeasureTime frameDescription
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.Within 30 minutes after extubationPediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scaleWithin 30 minutes after extubation.Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).

Secondary

MeasureTime frameDescription
extubation timeWithin 30 minutes after extubation.
post-operative pain using FLACC scoreWithin 30 minutes after extubation.The FLACC scale is used to assess postoperative pain in children. It consists of 5 categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, giving a total score range of 0-10.
emergence time from anesthesiaWithin 30 minutes after extubation.
Post operative nausea and vomittingWithin 30 minutes after extubation.
Hemodynamic effects as hypotention and bradycardiaWithin 30 minutes after extubation.
peaked PAED scoresWithin 30 minutes after extubation.Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

Countries

Egypt

Contacts

Primary ContactHesham Bahaaeldin Mohamed, Resident doctor
heshambahaa51@gmail.com+201069896083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026