Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

Benha University

Status: Enrolling

Conditions: Intravenous Anesthesia; Emergence Delirium; Sevoflurane

Treatments: Drug: sevoflurane; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06396468

RC 28-11-2023

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

sevoflurane group

Experimental group

Description:

Anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1

Treatment:

Drug: sevoflurane

Propofol group

Experimental group

Description:

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

Treatment:

Drug: propofol