NCT Number: NCT06436638
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Erciyes University Faculty of Dentistry, Kayseri, Turkey (Türkiye)
In the study to be conducted in two dental faculties, it is planned to use a total of 60 patient data, 30 patients with nasal CPAP mask and 30 patients with nasal airway. In the centers where the study will be conducted, deep sedation during dental procedures with ventilatory support via nasal airway and nasal CPAP mask, which will be compared in the study, is applied in routine practice. In this context, anxiolysis with 2 mg IV midazolam is administered to the patients before they are taken to the operating room on the day of the procedure. Patients are administered 1.5 mg/kg propofol and 0.5 mcg/kg fentanyl intravenously for sedation induction. Non-invasive ventilation support is then applied with a nasal airway or nasal CPAP mask and ventilation parameters are screened. Sevoflurane at 1 MAC (minimum alveolar concentration) level is administered inhalationally for sedation maintenance and the level of sedation is evaluated using the Ramsey sedation scale. Surgical dental extraction procedures between 20-60 minutes will be included in the study. For postoperative analgesia, paracetamol 1 g and dexketoprofen trometamol 50 mg are administered intravenously. The data planned to be collected within the scope of the study are blood pressure, heart rate, peripheral oxygen saturation (number of desaturation episodes), respiratory rate, ventilation parameters (Tidal volume (TV); set and actual, minute volume , end tidal CO2-EtCO2, and Peak pressure (Peak P). The total dose of agents used for sedation will also be recorded. During the post-operative follow-up period, the presence of nausea-vomiting, nasal pain, dryness in the nasal mucosa, epistaxis, sore throat, and dryness in the throat will be evaluated. Patient and surgeon satisfaction scores will be recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive ventilation support is provided by nasal airway and nasal CPAP mask to avoid respiratory complications such as hypoxia, desaturation, hypercarbia, respiratory depression etc. during extraction of impacted molars under deep sedation.
Time frame: Intraoperative period and for 4 hours after surgery
It is planned to record non-invasive blood pressure values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in blood pressure above 20% from baseline will be recorded additionally.
Time frame: Intraoperative period and for 4 hours after surgery
It is planned to record heart rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in heart rate greater than 20% of baseline will be recorded additionally.
Time frame: Intraoperative period and for 4 hours after surgery
It is planned to record peripheral oxygen saturation values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Hypoxia (SpO2<90%) will be recorded additionally.
Time frame: Intraoperative period and for 4 hours after surgery
It is planned to record respiratory rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Respiratory depression will be recorded additionally.
Time frame: Intraoperative period
Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded
Time frame: Intraoperative period
During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.
Time frame: Intraoperative period
During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.
Time frame: Intraoperative period
During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.
Time frame: Intraoperative period
During non-invasive ventilatory support, minute ventilation values will be recorded.
Time frame: During the next 3 hours after the end of the operation
During the recovery unit and inpatient ward follow-up, patients will be monitored for the presence of nausea/vomiting, pain and/or itching/dryness in the nose and/or throat. A 10-point Likert scale would be used for nausea and vomiting assessment (0 points: No nausea, 1-2 points: Very mild nausea, 3-4 points: Mild nausea, 5-6 points: Moderate nausea, 7-8 points: Severe nausea and 9-10 points: worst nausea). For pain, a 10-point visual analog scale would be used. Additionally, the development of epistaxis will be recorded.
Time frame: Perioperative period
Using a 5-point Likert scale, the satisfaction level of the patients and the surgeon will be questioned and recorded. In the Likert scale, 5 indicates the highest level of satisfaction and 1 indicates the lowest level of satisfaction.
Time frame: Intraoperative period
The total dose of anesthetic medications required to provide a depth of sedation with a Ramsey sedation score of 5 or higher during the surgical procedure will be recorded
Time frame: From the end of the operation until discharge to the ward
The time until the Modified Aldrete Score is 9 or higher during the recovery period
Contact information is provided by the study sponsor or research team.
Gözde Nur Erkan
Other
Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Terms of Intraoperative Anesthesia Quality and Postoperative Associated Complications in Impacted Molar Tooth Extraction Patients Under Deep Sedation; A Multi-Center Study
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