This Study Evaluated the Safety of Awake Extubation in Children at Risk for Respiratory Events Undergoing General Anesthesia.

NCT06936761 | Completed FDA Drug

• 2 other identifiers: F00507/2024
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. This study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks by identifying potential differences in airway-related adverse events between the two agents.

Conditions

Respiratory Tract Infection

Keywords

awake extubation; general anesthesia; children; sevoflurane

Outcome Measures

Primary Outcomes (3)

• The primary outcome was defined as a drop in oxygen saturation (SpO₂) below 95% lasting longer than 10 seconds.

  Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided.

  10 sec

• Serious risk factors (in ASA I and II patients): Laryngospasm Bronchospasm

  3 Hours in PACU

• Minor Risk factors: Airway obstruction Severe coughing Postoperative stridor

  3 Hours in PACU

Study Arms (2)

Sevoflurane (8% in oxygen 2% and air 2%)

Inhaler induction with sevoflurane 8% in oxygen 2% and air 2%, intravenous induction with propofol (3-5 mg/kg)

Drug: Sevoflurane

propofol (3-5 mg/kg IV)

This is a retrospective study about rottenly used anesthesia drugs.

Drug: Propofol

Interventions

Propofol DRUG

This is an observational study about routines of anesthesia induction and extubation

propofol (3-5 mg/kg IV)

Sevoflurane DRUG

This is a retrospective evolution of anesthesia drugs used routinely in an anesthesia clinic.

Also known as: propofol

Sevoflurane (8% in oxygen 2% and air 2%)

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

425 children (aged 2 to 13) underwent elective dental rehabilitation under general anesthesia. During preoperative anesthesia evaluations, an anesthesia research nurse who was unaware of the study protocol administered a modified ISAAC (International Study of Asthma and Allergies in Childhood) questionnaire. The presence of one or more risk factors for PRAEs was recorded, including a cold or flu within the previous two weeks, wheezing more than three times in the past 12 months, wheezing during exercise, dry nocturnal cough, current or past eczema, two family members with asthma, two family members with eczema, two family members with hay fever, and smoking by the mother or both parents.

You may qualify if:

• At least have one criteria of the ISAAC questionnaire
• ASA1\&2

You may not qualify if:

• cardiac disease
• airway or thoracic malformations
• ASA3

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Dentistry

Konya, Selcuklu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assis. Prof.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: December 1, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 31, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)