## Protocol Section
### Identification Module
**NCT ID:** NCT06430957

**Brief Title:** OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

**Official 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

#### Organization Study ID Info
**ID:** KU-ERKAN-002
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2025-08-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** TC Erciyes University

#### Lead Sponsor

**Class:** OTHER

**Name:** Kırıkkale University

#### Responsible Party

**Investigator Affiliation:** Kırıkkale University

**Investigator Full Name:** Gözde Nur Erkan

**Investigator Title:** Assistant Professor Doctor, Medical Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Obstructive Sleep Apnea Risk Management

- Postoperative Complications

- Dental Caries Under General Anesthesia

- Obstructive Sleep Apnea of Adult

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: The STOP-BANG questionnaire for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group lowSTOP-B

#### Arm Group 2

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

**Intervention Names:**

- Other: The STOP-BANG questionnaire for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group intermediateSTOP-B

#### Arm Group 3

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

**Intervention Names:**

- Other: The STOP-BANG questionnaire for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group highSTOP-B

#### Arm Group 4

**Description:** The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA.

**Intervention Names:**

- Other: ASA recommended criteria for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group noneASA

#### Arm Group 5

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

**Intervention Names:**

- Other: ASA recommended criteria for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group mildASA

#### Arm Group 6

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

**Intervention Names:**

- Other: ASA recommended criteria for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group moderateASA

#### Arm Group 7

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

**Intervention Names:**

- Other: ASA recommended criteria for determining OSA risk level.

- Other: Record of postoperative complications

**Label:** Group severeASA

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group highSTOP-B

- Group intermediateSTOP-B

- Group lowSTOP-B

**Description:** 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.

**Name:** The STOP-BANG questionnaire for determining OSA risk level.

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group mildASA

- Group moderateASA

- Group noneASA

- Group severeASA

**Description:** 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.

**Name:** ASA recommended criteria for determining OSA risk level.

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Group highSTOP-B

- Group intermediateSTOP-B

- Group lowSTOP-B

- Group mildASA

- Group moderateASA

- Group noneASA

- Group severeASA

**Description:** 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.

**Name:** Record of postoperative complications

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Determination of OSA risk levels of patients

**Time Frame:** Preoperative period

**Description:** 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.

**Measure:** Postoperative respiratory complications

**Time Frame:** For 4 hours after the end of surgery

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

**Measure:** Follow-up of indicators of airway obstruction

**Time Frame:** For 4 hours after the end of surgery

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

**Measure:** Duration of recovery

**Time Frame:** For 30 minutes after the end of surgery

#### Secondary Outcomes

**Description:** 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.

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

**Time Frame:** Perioperative period

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr.gozdenur@gmail.com

**Name:** Gözde Nur Erkan, Asst. Prof.

**Phone:** +905054334692

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017001

- Term: Tooth Demineralization

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: HIGH

- As Found: Apnea

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea

- ID: M6928

- Name: Dental Caries

- Relevance: HIGH

- As Found: Dental Caries

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M19339

- Name: Tooth Demineralization

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003731

- Term: Dental Caries

- ID: D000001049

- Term: Apnea

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

- ID: D000011183

- Term: Postoperative Complications

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
