Clinical trial

Emergence Delirium in Pediatric Age Group: Comparison Between Sevoflurane and Intravenous Anesthesia in Hypospadias Repair: A Randomized Clinical Trial

Name
RC 28-11-2023
Description
Emergence agitation (EA), a phenomenon observed at the time of recovery from general anesthesia (GA).The cause of ED appears to be multifactorial in origin. Use of volatile anesthetics, prolonged duration and type of surgery, pain, and rapid emergence are some factors known to increase its incidence
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-06-26
Trial end
2024-07-26
Status
Recruiting
Treatment
sevoflurane
sevoflurane (1-1.2 MAC)
Arms:
sevoflurane group
Other names:
S group
propofol
100-400 mcg/kg /min of propofol
Arms:
Propofol group
Other names:
P group
Size
90
Primary endpoint
Emergence delirium
24 hours
Eligibility criteria
Inclusion Criteria: * ages 1 to 8 years * American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair Exclusion Criteria: * children with a history of active airway disease, * sleep apnoea, developmental delay, * psychological, * neurological disorder, * cardiovascular abnormality or requirement of post-operative ventilation, * hepatic impairment, and renal insufficiency, with active upper respiratory tract infection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In group Sevoflurane, anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1.\n\nIn group propofol , anesthesia was maintained continuous infusion of 100-400 mcg/kg /min of propofol and fentanyl 0.1 ug / kg/ min with oxygen /air 1:1.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-05-02

1 organization

2 products

3 indications

Organization
Benha University
Indication
Sevoflurane
Product
propofol