- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430957
OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia
March 19, 2026 updated by: Gözde Nur Erkan, Kırıkkale University
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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gözde Nur Erkan, Asst. Prof.
- Phone Number: +905054334692
- Email: dr.gozdenur@gmail.com
Study Locations
-
-
-
Kayseri, Turkey (Türkiye)
- Recruiting
- Erciyes University Faculty of Dentistry
-
Contact:
- Dilek Günay Canpolat
- Email: dgcanpolat@gmail.com
-
Kırıkkale, Turkey (Türkiye)
- Recruiting
- Kırıkkale University Faculty of Dentistry
-
Contact:
- Gözde Nur Erkan
- Phone Number: 7140 +903182244927
- Email: dr.gozdenur@gmail.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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.
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group lowSTOP-B
Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire.
|
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.
|
|
Group intermediateSTOP-B
Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire.
|
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.
|
|
Group highSTOP-B
Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire.
|
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.
|
|
Group noneASA
The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA.
|
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.
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.
|
|
Group mildASA
Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA.
|
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.
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.
|
|
Group moderateASA
Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA.
|
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.
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.
|
|
Group severeASA
Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative period
|
|
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.
|
For 4 hours after the end of surgery
|
|
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.
|
For 4 hours after the end of surgery
|
|
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
|
For 30 minutes after the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Perioperative period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
June 28, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
May 14, 2024
First Submitted That Met QC Criteria
May 24, 2024
First Posted (Actual)
May 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU-ERKAN-002
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.
Clinical Trials on Postoperative Complications
-
Twin Cities Spine CenterAllina Health SystemRecruitingComplications, PostoperativeUnited States
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainCompletedComplications, PostoperativeUnited States
-
Yale UniversityRecruitingPostoperative Complications (Cardiopulmonary)United States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Wake Forest University Health SciencesTerminatedPerioperative/Postoperative ComplicationsUnited States
-
Technical University of MunichHealth Information Management, BelgiumActive, not recruitingPerioperative/Postoperative Complications
-
Atatürk Chest Diseases and Chest Surgery Training...CompletedPerioperative/Postoperative ComplicationsTurkey
Clinical Trials on The STOP-BANG questionnaire for determining OSA risk level.
-
University Hospital, CaenCompletedAged Patients Treated for Cancer in OutclinicsFrance
-
Central Hospital, Nancy, FranceRecruitingCardiovascular Diseases | Risk Factors | Nutrition | Cohort Studies | GenotypeFrance
-
University Health Network, TorontoUniversity of TorontoRecruiting
-
University of Ljubljana, Faculty of MedicineUniversity Medical Centre Ljubljana; University Maribor; University Psychiatric...RecruitingNon-Suicidal Self Injury | Self-harm | Personality Disorder, Borderline | Difference, Individual | Epigenetic Disorder | Change; MentalSlovenia