A Phase 4 interventional study of Propofol and Lidocaine %2 ampoule in Emergence Delirium, Anesthesia, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Assiut University · Phase 4, Interventional, and Prevention
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.
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 ?
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's planned enrollment of 82 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
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Exclusion Criteria:
Drug: Propofol
Drug: Lidocaine %2 ampoule
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
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.
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
Time frame: 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
Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).
Time frame: Within 30 minutes after extubation.
emergence time from anesthesia
Time frame: Within 30 minutes after extubation.
peaked PAED scores
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
Time frame: Within 30 minutes after extubation.
extubation time
Time frame: Within 30 minutes after extubation.
post-operative pain using FLACC score
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.
Time frame: Within 30 minutes after extubation.
Hemodynamic effects as hypotention and bradycardia
Time frame: Within 30 minutes after extubation.
Post operative nausea and vomitting
Time frame: Within 30 minutes after extubation.
Plan to share: Yes
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Assiut University