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

December 4, 2025 updated by: Hesham Bahaa-eldin Mohamed, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group ( p ) recieve 1mg /kg of propofol
Drug: Propofol
In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus
Active Comparator: Group ( L ) recieve 1.5 mg/kg of lidocaine
Drug: Lidocaine %2 ampoule
In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 30 minutes after extubation
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).
Within 30 minutes after extubation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence time from anesthesia
Time Frame: Within 30 minutes after extubation.
Within 30 minutes after extubation.
peaked PAED scores
Time Frame: Within 30 minutes after extubation.
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
Within 30 minutes after extubation.
extubation time
Time Frame: Within 30 minutes after extubation.
Within 30 minutes after extubation.
post-operative pain using FLACC score
Time Frame: Within 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.
Within 30 minutes after extubation.
Hemodynamic effects as hypotention and bradycardia
Time Frame: Within 30 minutes after extubation.
Within 30 minutes after extubation.
Post operative nausea and vomitting
Time Frame: Within 30 minutes after extubation.
Within 30 minutes after extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA-CHT-PvL-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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