Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396468
• Other study ID #: RC 28-11-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 26, 2024

Study information

• Verified date: February 2024
• Source: Benha University
• Contact: Ramy Saleh, MD
• Phone: 01024020922
• Email: ramymousa455[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Hypospadias
• Intravenous Anesthesia
• Sevoflurane

Intervention

Drug:
• sevoflurane
sevoflurane (1-1.2 MAC)
• propofol
100-400 mcg/kg /min of propofol

Locations

Country	Name	City	State
Egypt	Benha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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