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NCT Number: NCT06430957

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erciyes University Faculty of Dentistry, Kayseri, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia
  • Patients without a previous diagnosis of OSA

Exclusion criteria

  • Individuals who do not want to participate in the study
  • Patients previously diagnosed with OSA
  • Necessity of emergency surgery

Treatment and study plan

The STOP-BANG questionnaire for determining OSA risk level.

Other

An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician.

ASA recommended criteria for determining OSA risk level.

Other

An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician.

Record of postoperative complications

Other

Respiratory complications as laryngospasm/bronchospasm, apnea, hypoxia, duration and amount of need for additional oxygen support and recovery time (duration of modified aldrete score of 9 and above) will be recorded.

Primary outcomes

  1. Determination of OSA risk levels of patients

    Time frame: Preoperative period

    The STOP-BANG questionnaire and the criteria recommended by the ASA, which are recommended to be used routinely worldwide to determine OSA risk level, will be questioned in each patient. Patients with moderate and high risk scores from the STOP-BANG questionnaire and patients with significant OSA risk level according to ASA criteria will be referred to the pulmonology department and further evaluation will be requested. If deemed necessary by the Pulmonology department, a sleep test will be performed. With the sleep test result, the OSA risk level of the patients will be classified as none, mild, moderate and severe in terms of ASA criteria.

  2. Postoperative respiratory complications

    Time frame: For 4 hours after the end of surgery

    Respiratory complications including laryngospasm/bronchospasm, apnea, hypoxia that may develop in the postoperative period in patients, the duration of the need for additional oxygen support above the expected duration will be observed and recorded.

  3. Follow-up of indicators of airway obstruction

    Time frame: For 4 hours after the end of surgery

    As indicators of airway obstruction; snoring/whistling respiration, hypertension and intercostal/sternal retractions will be observed and recorded in the study follow-up form.

  4. Duration of recovery

    Time frame: For 30 minutes after the end of surgery

    Duration of recovery (modified aldrete score of 9 and above) will be recorded

Secondary outcomes

  1. Comparison of the effectiveness of STOP-BANG questionnaire and ASA criteria in determining OSA risk level

    Time frame: Perioperative period

    Patients who will receive an intermediate or high risk score from either of the two assessment questionnaires will be referred for further evaluation and diagnosis of suspected OSA. At the end of the diagnostic process, it is planned to investigate which of the two scoring systems more successfully identifies patients with OSA and assigns a higher risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Gözde Nur Erkan, Asst. Prof.

CONTACT

[email protected]

+905054334692

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Collaborators

  • TC Erciyes University

Registry information

Official study title

Evaluation of OSA Risk Levels in the Preoperative Period of Adult Patients With Planned Dental Procedures Under Anesthesia and Correlation With Postoperative Complications; A Multicenter Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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