Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

NCT06396468 | Recruiting

• 1 other identifier: RC 28-11-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Emergence Delirium; Intravenous Anesthesia; Sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• FLACC

  Postoperatively at 24 hours

Study Arms (2)

sevoflurane group

EXPERIMENTAL

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

Drug: sevoflurane

Propofol group

EXPERIMENTAL

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

Interventions

sevoflurane DRUG

sevoflurane (1-1.2 MAC)

Also known as: S group

sevoflurane group

propofol DRUG

100-400 mcg/kg /min of propofol

Also known as: P group

Propofol group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages 1 to 8 years
• American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Ramy Saleh, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramy Saleh, MD

CONTACT

01024020922; ramymousa455@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 2, 2024
• Study Start: March 1, 2024
• Primary Completion: June 26, 2024
• Study Completion: July 26, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)