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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430957
• Other study ID #: KU-ERKAN-002
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: August 20, 2025

Study information

• Verified date: May 2024
• Source: Kirikkale University
• Contact: Gözde Nur Erkan, Asst. Prof.
• Phone: +905054334692
• Email: dr.gozdenur[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: August 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Dental Caries
• Obstructive Sleep Apnea of Adult
• Postoperative Complications
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kirikkale University	TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative period
Primary	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.	For 4 hours after the end of surgery
Primary	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.	For 4 hours after the end of surgery
Primary	Duration of recovery	Duration of recovery (modified aldrete score of 9 and above) will be recorded	For 30 minutes after the end of surgery
Secondary	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.	Perioperative period