NCT06436638 Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 60 participants in total. It began in 2024-07-02 with a primary completion date of 2026-05.

Brief Summary

In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior. During dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature. The aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction. The hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction. In the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \>0.8. The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.

Eligibility Criteria

Inclusion Criteria: * Volunteer adult patients aged 18-60 years * Patients scheduled for impacted tooth extraction * Cases with surgical time ≥20 minutes and ≤60 minutes * American Society of Anaesthesiologists (ASA) physical status I and II patients * Patients with BMI≤30 Exclusion Criteria: * Patients under 18 years old-over 60 years old * Surgeries with a procedure time over 1 hour or less than 20 minutes * American Society of Anaesthesiologists (ASA) physical status III and higher patients * Presence of conditions such as mental retardation that impair the patient's ability to make decisions about himself/herself * Patients with respiratory system diseases such as asthma, chronic obstructive pulmonary disease (COPD) or airway hyperreactivity * Patients with a condition that severely narrows the nasal passage opening (e.g. adenoid hypertrophy, etc.) * Patients with BMI\>30 * Patients who refused to participate in the study

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