Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children

December 4, 2025 updated by: Safaa Gaber Ragab, Fayoum University Hospital

Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)

During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . This vulnerability to hypoxemia underscores the critical need for effective oxygenation strategies during anesthesia. Apneic oxygenation, the provision of oxygen without concurrent tidal volume delivery, emerges as a vital technique in pediatric anesthesia, playing a pivotal role in both routine and challenging airway management scenarios .

In modern practice, apneic oxygenation during airway management denotes the uninterrupted supply of oxygen, extending the window for maintaining safe oxygen saturation levels during the apneic phase . This technique holds particular significance in pediatric patients undergoing adenotonsillectomy, where the delicate balance of oxygenation is paramount .

Adenotonsillectomy, a common surgical procedure in pediatric patients, poses unique challenges in airway management . The procedure involves the removal of the adenoids and tonsils, often necessitating general anesthesia and temporary airway obstruction . Furthermore, the potential for blood and secretions in the oropharynx increases the risk of airway compromise during the perioperative period. In this context, ensuring adequate oxygenation is essential to mitigate the risk of hypoxemia and its associated complications In this randomized clinical trial, the investigators aim to evaluate the efficacy and safety of apneic oxygenation using nasal cannula in pediatric patients undergoing adenotonsillectomy under general anesthesia. By assessing our primary outcome and secondary outcomes, the investigators seek to contribute valuable insights into optimizing anesthesia management protocols for this vulnerable patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following permission from the local institutional review board and institutional ethics committee, this study will be carried out at the FAYOUM University hospital. The research will employ a single -blinded, randomized, and controlled approach.

Prior to recruitment and randomization, detailed consent will be obtained from the parents or legal guardians of eligible patients.

Patients were randomly allocated 1: 1 to the two study groups:

Group (A):

Patients in the group A will undergo tracheal intubation without apneic oxygenation

Group (B):

Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula The randomization will be computer generated random number and the randomization sequence will be kept hidden in sealed opaque envelopes just opened after recruitment and admittance to the operating room. The group's allocations will be only blinded to parents of children.

In both the control and experimental groups, subjects will undergo a standardized general anesthesia protocol. All pediatric participants will receive premedication in the form of 0.5 mg/kg rectal midazolam upon admission to the operating theater, patients will be comfortably positioned on the operating table. Standard monitoring devices, including electrocardiography (ECG), non-invasive blood pressure (NIBP) measurement, pulse oximetry, and end-tidal carbon dioxide (EtCO2) monitoring, will be affixed. Intravenous access will be established to facilitate fluid and medication administration. In instances where venous access proves challenging, patients will be induced with inhaled sevoflurane at 8% concentration, followed by the insertion of an intravenous cannula. Subsequently, anesthetic induction will be achieved using a combination of 2 - 3 mg/kg of Propofol, 1 mcg/kg of Fentanyl, and 0.5 mg/kg of Atracurium. Following induction, bag-mask ventilation with 100% oxygen and flow rates of 6-8 litres min will be initiated for 3 minutes Ventilation will then be discontinued. In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.

Following intubation, SpO2 levels will be recorded, and mechanical ventilation will be instituted to maintain normocapnia and oxygenation within predetermined target ranges.

In case of desaturation, the procedure will be discontinued as soon as the SpO2 reach 92%. Bag mask ventilation with 100% oxygen will be started until spo2 reach 100%, Intubation will then be performed by the supervising consultant anesthesiologist

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Fayyum, Egypt
        • Fayoum University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients (3 - 10 Years).
  • Patients who were scheduled for adenotonsillectomy.
  • ASA I and II

Exclusion Criteria:

  • When nasal intubation is needed.
  • Patients reported with nasal obstruction.
  • Patients with any respiratory disease like asthma or recent upper respiratory tract infection.
  • Patients with obstructive sleep apnea
  • Patients with congenital heart disease
  • Patients suspected difficult intubation or syndromatic patients eg : down syndrome , Goldenhar Syndrome , Pierre Robin syndrome … etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Patients in the group A will undergo tracheal intubation without apneic oxygenation
Experimental: apniec oxygenation group
Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula
Device: nasal cannula
In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lowest oxygen saturation during tracheal intubation.
Time Frame: at the end of intubation procedure
Following intubation, SpO2 levels will be recorded
at the end of intubation procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients that their spo2 dropped to 95%.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Number of patients that their spo2 dropped to 92%.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Number of patients that their spo2 dropped to below 92%.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Spo2 base line Spo2 after bag and mask ventillation and Spo2 immediately after intubation.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Number of intubation attempts.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Time of intubation.
Time Frame: at the end of intubation procedure
at the end of intubation procedure
Number of patients developed bradycardia.
Time Frame: at the end of the study ( 6 months )
at the end of the study ( 6 months )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Safaa Gaber Ragab, MD, Faculty of medicine, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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