Sevoflurane and Intravenous Anesthesia in Hypospadias Repair

NCT ID: NCT06396468

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-07-26

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

Conditions

Emergence Delirium; Intravenous Anesthesia; Sevoflurane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

sevoflurane group

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

Group Type: EXPERIMENTAL

sevoflurane

Intervention Type: DRUG

sevoflurane (1-1.2 MAC)

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

Group Type: EXPERIMENTAL

propofol

Intervention Type: DRUG

100-400 mcg/kg /min of propofol

Interventions

sevoflurane

sevoflurane (1-1.2 MAC)

Intervention Type: DRUG

propofol

100-400 mcg/kg /min of propofol

Intervention Type: DRUG

Other Intervention Names

S group; P group

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ramy Mousa

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramy Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Benha University

Banhā, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ramy Saleh, MD

Role: CONTACT

ramymousa455@gmail.com

01024020922 ext. 139

Facility Contacts

Ramy Saleh, MD

Role: primary

ramymousa455@gmail.com

01024020922 ext. 139

Other Identifiers

RC 28-11-2023

Identifier Type: -

Identifier Source: org_study_id