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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06396468
Other study ID # RC 28-11-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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