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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorKırıkkale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals who do not want to participate in the study

Patients previously diagnosed with OSA

Necessity of emergency surgery

Trial population

Patients between the ages of 18-80 years who applied to the anesthesia clinic for dental procedures planned to be performed under general anesthesia and who had no previous diagnosis of OSA.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • The STOP-BANG questionnaire for determining OSA risk level.

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

240 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group lowSTOP-B2 interventions
Group B: Group intermediateSTOP-B2 interventions
Group C: Group highSTOP-B2 interventions
Group D: Group noneASA2 interventions
Group E: Group mildASA2 interventions
Group F: Group moderateASA2 interventions
Group G: Group severeASA2 interventions

Trial outcomes

Primary outcomes

1

Determination of OSA risk levels of patients

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.

Time frame
Preoperative period
2

Postoperative respiratory complications

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.

Time frame
For 4 hours after the end of surgery
3

Follow-up of indicators of airway obstruction

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

Time frame
For 4 hours after the end of surgery
4

Duration of recovery

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

Time frame
For 30 minutes after the end of surgery

Secondary outcomes

1

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

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.

Time frame
Perioperative period

Other outcomes

Sponsors and contacts

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Kırıkkale University

Lead sponsor

TC Erciyes University

Collaborator