Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436638
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-10
Brief Title:
Comparison of Nasal Continuous Positive Airway Pressure CPAP Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation
Sponsor:
Gözde Nur Erkan
Organization:
Kırıkkale University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 challengesSince 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 n30 Group Mask n30 from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial 08
The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included
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 challengesSince 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 n30 Group Mask n30 from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial 08
The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included
Detailed 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 15 mgkg propofol and 05 mcgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None