An observational study in Obstructive Sleep Apnea Risk Management, Postoperative Complications and Dental Caries Under General Anesthesia, sponsored by Kırıkkale University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Kırıkkale University · Observational
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 240 is close to the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Kırıkkale University is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire.
Other: The STOP-BANG questionnaire for determining OSA risk level. · Other: Record of postoperative complications
Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire.
Other: The STOP-BANG questionnaire for determining OSA risk level. · Other: Record of postoperative complications
Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire.
Other: The STOP-BANG questionnaire for determining OSA risk level. · Other: Record of postoperative complications
The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA.
Other: ASA recommended criteria for determining OSA risk level. · Other: Record of postoperative complications
Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA.
Other: ASA recommended criteria for determining OSA risk level. · Other: Record of postoperative complications
Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA.
Other: ASA recommended criteria for determining OSA risk level. · Other: Record of postoperative complications
Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA.
Other: ASA recommended criteria for determining OSA risk level. · Other: Record of postoperative complications
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.
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.
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.
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
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
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
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Aug 2026, 26 months after the start.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 26 months is above that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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