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Clinical Trials/NCT06396468
NCT06396468
Recruiting
Not Applicable

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

Benha University1 site in 1 country90 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
sevoflurane
Conditions
Emergence Delirium
Sponsor
Benha University
Enrollment
90
Locations
1
Primary Endpoint
Emergence delirium
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
July 26, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ramy Mousa

Professor of Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Benha University

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

Arms & Interventions

sevoflurane group

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

Intervention: sevoflurane

Propofol group

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

Intervention: propofol

Outcomes

Primary Outcomes

Emergence delirium

Time Frame: 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 Outcomes

  • FLACC(Postoperatively at 24 hours)

Study Sites (1)

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