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

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

Study Overview

• Status: Recruiting
• Conditions: Emergence Delirium; Sevoflurane; Intravenous Anesthesia
• Intervention / Treatment: Drug: sevoflurane; Drug: propofol

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramy Saleh, MD; Phone Number: 139 01024020922; Email: ramymousa455@gmail.com

Study Locations

• Egypt
  • Banha, Egypt, 13511
    • Recruiting
    • Benha University
    • Contact: Ramy Saleh, MD; Phone Number: 139 01024020922; Email: ramymousa455@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sevoflurane group; Anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1	Drug: sevoflurane; sevoflurane (1-1.2 MAC); Other Names: S group
Experimental: 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	Drug: propofol; 100-400 mcg/kg /min of propofol; Other Names: P group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence delirium	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC	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	Postoperatively at 24 hours

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 26, 2024
• Study Completion (Estimated): July 26, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Delirium; Emergence Delirium; Hypospadias; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: RC 28-11-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No