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Clinical Trials/NCT07268924
NCT07268924
Not yet recruiting
Phase 4

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

Assiut University1 site in 1 country82 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
82
Locations
1
Primary Endpoint
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.

Overview

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 ?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
4 Years to 7 Years (Child)
Sex
All
Accepts 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

Arms & Interventions

Group ( p ) recieve 1mg /kg of propofol

Active Comparator

Intervention: Propofol (Drug)

Group ( L ) recieve 1.5 mg/kg of lidocaine

Active Comparator

Intervention: Lidocaine %2 ampoule (Drug)

Outcomes

Primary Outcomes

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.

Time Frame: Within 30 minutes after extubation

Pediatric 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 scale

Time Frame: Within 30 minutes after extubation.

Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).

Secondary Outcomes

  • emergence time from anesthesia(Within 30 minutes after extubation.)
  • peaked PAED scores(Within 30 minutes after extubation.)
  • extubation time(Within 30 minutes after extubation.)
  • post-operative pain using FLACC score(Within 30 minutes after extubation.)
  • Hemodynamic effects as hypotention and bradycardia(Within 30 minutes after extubation.)
  • Post operative nausea and vomitting(Within 30 minutes after extubation.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hesham Bahaa-eldin Mohamed

Resident doctor at anesthesia & ICU depatrtment

Assiut University

Study Sites (1)

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