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

Deep Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436638
• Other study ID #: KU-ERKAN-001
• Status: Not yet recruiting
• Start date: June 3, 2024
• Est. completion date: June 3, 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 3, 2025
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Tooth, Impacted

Intervention

Device:
• Non-invasive ventilation support equipment
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Gözde Nur Erkan	Kirikkale University, TC Erciyes University

References & Publications (3)

Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016. — View Citation

Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052. — View Citation

Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3. Erratum In: J Clin Anesth. 2023 Nov 20;:111346. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive blood pressure	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.	Intraoperative period and for 4 hours after surgery
Primary	ECG	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.	Intraoperative period and for 4 hours after surgery
Primary	Peripheral oxygen saturation	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.	Intraoperative period and for 4 hours after surgery
Primary	Respiratory rate	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.	Intraoperative period and for 4 hours after surgery
Primary	Number of interruptions for an anesthesia-related reason	Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded	Intraoperative period
Primary	Tidal volume	During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.	Intraoperative period
Primary	Peak pressure	During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.	Intraoperative period
Primary	End tidal carbon dioxide level (EtCO2)	During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.	Intraoperative period
Primary	Minute ventilation	During non-invasive ventilatory support, minute ventilation values will be recorded.	Intraoperative period
Secondary	Postoperative complications related non-invasive ventilation support devices and sedation	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.	During the next 3 hours after the end of the operation
Secondary	Patient and surgeon satisfaction	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.	Perioperative period
Secondary	Total dose of medications used for sedation during the procedure	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	Intraoperative period
Secondary	Recovery duration from anesthesia	The time until the Modified Aldrete Score is 9 or higher during the recovery period	From the end of the operation until discharge to the ward