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

NCT ID: NCT06430957

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-28

Study Completion Date

2026-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Risk Management Postoperative Complications Dental Caries Under General Anesthesia Obstructive Sleep Apnea of Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group lowSTOP-B

Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire.

The STOP-BANG questionnaire for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Group intermediateSTOP-B

Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire.

The STOP-BANG questionnaire for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Group highSTOP-B

Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire.

The STOP-BANG questionnaire for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

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.

ASA recommended criteria for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Group mildASA

Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA.

ASA recommended criteria for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Group moderateASA

Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA.

ASA recommended criteria for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Group severeASA

Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA.

ASA recommended criteria for determining OSA risk level.

Intervention Type 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

Intervention Type 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.

Interventions

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The STOP-BANG questionnaire for determining OSA risk level.

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.

Intervention Type OTHER

ASA recommended criteria for determining OSA risk level.

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.

Intervention Type OTHER

Record of postoperative complications

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role collaborator

Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

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Gözde Nur Erkan

Assistant Professor Doctor, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erciyes University Faculty of Dentistry

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Kırıkkale University Faculty of Dentistry

Kırıkkale, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gözde Nur Erkan, Asst. Prof.

Role: CONTACT

+905054334692

Facility Contacts

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Dilek Günay Canpolat

Role: primary

Gözde Nur Erkan

Role: primary

+903182244927 ext. 7140

Other Identifiers

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KU-ERKAN-002

Identifier Type: -

Identifier Source: org_study_id

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