Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

Not Applicable

Recruiting

• Conditions: Intravenous Anesthesia; Sevoflurane; Emergence Delirium
• Interventions: Drug: propofol; Drug: sevoflurane

• Registration Number: NCT06396468
• Lead Sponsor: Benha University

Brief Summary

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

Detailed Description

The pathogenesis of postoperative EA is still undefined, but sevoflurane has intrinsic effects that may share in emergence agitation like its different electroencephalogram pattern from halothane, and its degradation to inorganic fluoride ions and compound A which may have a role in the occurrence of EA Sevoflurane now is the inhalational anaesthetic agent of choice for pediatrics, as it is non-pungent, with minimal airway irritation characters, and its cardiac adverse effects are minimal like cardiac depression and dysrhythmias.

Total intravenous anesthesia (TIVA) using propofol and fentanyl appears to have a smooth recovery profile

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-03-01
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol 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
sevoflurane group	sevoflurane	Anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1

Primary Outcome Measures

Name	Time	Method
Emergence delirium	24 hours	The pediatric anesthesia emergence delirium (PAED) scale. Each must be evaluated as not at all, just a little, quite a bit, very much, or extremely, where the first three items to be scored reversely (4 = not at all, 0 = extremely) while the last two items to be scored regularly.

Secondary Outcome Measures

Name	Time	Method
FLACC	Postoperatively at 24 hours	The Face, Legs, Activity, Cry, and Consolability scale is a frequently used tool for pain assessment in children, with a total score of 0 to 10

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banha, Egypt