Skip to content

Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06396468
Enrollment
90
Registered
2024-05-02
Start date
2024-03-01
Completion date
2024-07-26
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Intravenous Anesthesia, Sevoflurane

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

Interventions

DRUGsevoflurane

sevoflurane (1-1.2 MAC)

DRUGpropofol

100-400 mcg/kg /min of propofol

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

In group Sevoflurane, anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1. In 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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence delirium24 hoursThe 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

MeasureTime frameDescription
FLACCPostoperatively at 24 hoursThe 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

Countries

Egypt

Contacts

Primary ContactRamy Saleh, MD
ramymousa455@gmail.com01024020922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026