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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ECG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group Airway
Group to receive non-invasive ventilation support via nasal airway during dental extraction under deep sedation.
干预措施: Non-invasive ventilation support equipment (Device)
Group Mask
Group to receive non-invasive ventilation support via nasal CPAP mask during dental extraction under deep sedation
干预措施: Non-invasive ventilation support equipment (Device)
结局指标
主要结局
ECG
时间窗: 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.
Peripheral oxygen saturation
时间窗: 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.
Non-invasive blood pressure
时间窗: 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.
Respiratory rate
时间窗: 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.
Number of interruptions for an anesthesia-related reason
时间窗: Intraoperative period
Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded
Tidal volume
时间窗: Intraoperative period
During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.
Peak pressure
时间窗: Intraoperative period
During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.
End tidal carbon dioxide level (EtCO2)
时间窗: Intraoperative period
During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.
Minute ventilation
时间窗: Intraoperative period
During non-invasive ventilatory support, minute ventilation values will be recorded.
次要结局
- Total dose of medications used for sedation during the procedure(Intraoperative period)
- Recovery duration from anesthesia(From the end of the operation until discharge to the ward)
- Patient and surgeon satisfaction(Perioperative period)
- Postoperative complications related non-invasive ventilation support devices and sedation(During the next 3 hours after the end of the operation)
研究者
Gözde Nur Erkan
Assistant Professor Doctor, Medical Doctor
Kırıkkale University