Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan

Not Applicable

Not yet recruiting

• Conditions: Emergence Agitation
• Interventions: Drug: Normal saline; Drug: Propofol

• Registration Number: NCT06218680
• Lead Sponsor: Khon Kaen University

Brief Summary

The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study Start: 2024-01-20
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Age 2-8 years
• ASA class I or II ,who schedule for MRI scan under sevoflurane anesthesia

Exclusion Criteria

• Developmental delay
• Psychological and neurological disorders
• Abnormal airway
• Reactive airway disease
• Allergy to propofol, egg product
• Family history of malignant hyperthermia
• Need iv sedative medication before induction
• Obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group S	Normal saline	Receive saline intravenously at end of sevoflurane anesthesia
group P	Propofol	Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia

Primary Outcome Measures

Name	Time	Method
incidence of emergence agitation	at 5,10,15,20,25,30 minutes after extubation

Secondary Outcome Measures

Name	Time	Method
Incidence of complication	2 hours after extubation	Nausea or vomiting, airway obstruction, laryngospasm, desaturation and apnea
Use of rescue medication	2 hours after extubation	use of ondansetron, atropine
Length of stay in post anesthetic care unit	2 hours after extubation
Emergence time	2 hours after extubation	duration of emergence

Trial Locations

Locations (1)

Khon kaen University; 🇹🇭 Khon Kaen, Muang, Thailand