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

NCT ID: NCT06936761

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 425 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Awake extubation is advantageous in ambulatory settings where patients are discharged on the same day, as it reduces the risk of airway-related complications during recovery and ensures a smoother transition to postoperative care. When children come in for dental treatments requiring GA, they can face higher chances of respiratory issues due to things like colds, asthma, or unique physical traits. The way we introduce anesthesia is important in helping prevent these complications. In this context, sevoflurane and propofol are two commonly used agents for the induction of anesthesia in children. Sevoflurane, a volatile anesthetic agent, is favored for its non-irritating nature and smooth induction process, particularly in pediatric patients. However, its use has been associated with a higher incidence of airway complications, including laryngospasm and coughing. On the other hand, propofol, a widely used intravenous (IV) agent, is known for its rapid onset and favorable recovery profile. It also reduces airway reflex responses, potentially decreasing the risk of respiratory complications during induction and emergence.

Current evidence suggests that extubating during emergence from anesthesia does not significantly alter clinical outcomes for healthy children. A large prospective cohort study examined a population at particularly high risk for perioperative respiratory adverse events (PRAEs). Additionally, a detailed analysis of the risk factors within the cohort suggested that the timing of extubation seemed to impact the occurrence of laryngospasm and severe complications of coughing.

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. By identifying potential differences in airway-related adverse events between the two agents, this study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks.

All children were extubated while awake when they demonstrated facial grimacing, adequate tidal volumes, an appropriate respiratory rate, coughing with an open mouth, opening their eyes, and purposeful movements. The anesthesiologist placed all children on 100% oxygen prior to extubation and transported them in the lateral position to the Post-Anesthesia Care Unit (PACU) after ensuring they could maintain adequate airway patency. Oxygen saturation was continuously monitored until discharge from the PACU. Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided. All incidents of laryngospasm, bronchospasm (serious risk factors; I, II), desaturation below 95%, airway obstruction, severe coughing, or postoperative stridor (minor risk factors; III, IV) were recorded, along with any airway interventions. The primary outcome measure for analysis was oxygen saturation below 95% for more than 10 seconds. However, shorter desaturation episodes were also captured since oxygen saturation was continuously recorded per institutional guidelines. Any treatment required in response to respiratory adverse events was documented.

Subsequently, the responsible anesthesiologist gathered and reviewed all relevant data from anesthesia and PACU records. Patients with known cardiac disease, airway, or thoracic malformations were excluded from the study.

Conditions

Respiratory Tract Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Sevoflurane

Intervention Type: DRUG

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

propofol (3-5 mg/kg IV)

This is a retrospective study about rottenly used anesthesia drugs.

Propofol

Intervention Type: DRUG

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

Interventions

Propofol

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

Intervention Type: DRUG

Sevoflurane

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

Intervention Type: DRUG

Other Intervention Names

propofol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• cardiac disease
• airway or thoracic malformations
• ASA3

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

FUNDA ARUN

Assis. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Selcuk University Faculty of Dentistry

Konya, Selcuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

07/2024

Identifier Type: OTHER

Identifier Source: secondary_id

F005

Identifier Type: -

Identifier Source: org_study_id