Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511128
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Evaluation of the Depth of Anesthesia With 4-Channel EEG in Patients Undergoing Drug-Induced Sleep Endoscopy DISE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Depth of Anesthesia With 4-Channel EEG in Patients Undergoing Drug-Induced Sleep Endoscopy DISE With Two Different Sedation Methods
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
You will undergo a drug-induced sleep endoscopy procedure The drugs we use to create routine sedation will be used as medication During the procedure your pulse blood pressure respiratory rate blood oxygen level and alertness will be monitored Your values will be closely monitored and recorded before during and after the procedure
Our study is a study that will not require any changes in the drug-induced sleep endoscopy DISE procedure and treatment plan you will undergo During drug-induced sleep endoscopy DISE your measurement values which we follow in every patient will be recorded An adhesive tape will be attached to your forehead area especially to determine your sleep depth It will be removed at the end of the procedure
Our study is a study that will not require any changes in the drug-induced sleep endoscopy DISE procedure and treatment plan you will undergo During drug-induced sleep endoscopy DISE your measurement values which we follow in every patient will be recorded An adhesive tape will be attached to your forehead area especially to determine your sleep depth It will be removed at the end of the procedure
Detailed Description:
Volunteer patients between the ages of 18-65 both genders and ASA American Society of Anesthesiology I-II risk scores who will undergo DISE with sedation after routine preoperative evaluation under elective conditions will be included in the studyAll patients participating in the study will be explained about the study and possible risks and informed consent will be obtained from the patients
Exclusion criteria for the study Patient unwillingness being younger than 18 years of age being older than 65 years of age patients with ASA score greater than II pregnant women drug addicts alcohol addicts patients with congestive heart failure need for intubation patients receiving oxygen therapy at home Patients with chronic analgesic use patients known to be allergic to the anesthetic drugs used patients with psychiatric disorders
The patient age weight BMI AHI index if any existing chronic diseases medications used whether or not CPAP has been used at home for how many years duration of the procedure amount of medications used whether the airway is intervened or not hemodynamicsystolic arterial pressure diastolic arterial pressure average parameters eg arterial pressure heart rate oxygen saturation will be recorded throughout the procedure
At the end of the procedure the patient will be taken to the recovery unit and will be evaluated according to Aldrete criteria and if there is no problem patient will be sent to the serviceThe patientamp39s wake-up time recovery time and possible complications during recovery will be noted and treatment will be planned
All patients entering the operating room will receive ASA monitoring non-invasive arterial blood pressure ECG oxygen saturation followed by 4-channel EEG monitoring and baseline values will be notedAfter a 4ltmin nasal oxygen cannula is placed 1 mg midazolam and 50 mcg fentanyl will be given to group I and then propofol infusion will be started at a dose of 50-100 mcgkgmin following an initial dose of 1mgkgIn group II infusion will be started at a dose of 02-07 mcgkgh after a loading dose of 1 mg midazolam 50 mcg fentanyl followed by 1 mcgkg dexmetedomidineAnesthesia depth dose adjustment will be made according to the 60-70 PSI value range in the 4-channel EEG The time to reach the adequate processing level will be recordedPatients who have reached the target depth of sedation but have hypertension will be given an additional 01 mg of glyceryl trinitrateDecreases of 25 from baseline blood pressure will be considered hypotension and will be treated with fluid boluses andor followed by IV ephedrineIn the event of apnea or desaturation airway management techniques such as patient stimulation increased oxygen supplementation chin lift chin thrust maneuver will be applied and noted
If the pulse rate drops below 50 bpm treatment with IV 05 mg atropine will be considered While the patient is being sent to the ward the patient will be asked whether he or she has had a dream and if so its content will be noted
Exclusion criteria for the study Patient unwillingness being younger than 18 years of age being older than 65 years of age patients with ASA score greater than II pregnant women drug addicts alcohol addicts patients with congestive heart failure need for intubation patients receiving oxygen therapy at home Patients with chronic analgesic use patients known to be allergic to the anesthetic drugs used patients with psychiatric disorders
The patient age weight BMI AHI index if any existing chronic diseases medications used whether or not CPAP has been used at home for how many years duration of the procedure amount of medications used whether the airway is intervened or not hemodynamicsystolic arterial pressure diastolic arterial pressure average parameters eg arterial pressure heart rate oxygen saturation will be recorded throughout the procedure
At the end of the procedure the patient will be taken to the recovery unit and will be evaluated according to Aldrete criteria and if there is no problem patient will be sent to the serviceThe patientamp39s wake-up time recovery time and possible complications during recovery will be noted and treatment will be planned
All patients entering the operating room will receive ASA monitoring non-invasive arterial blood pressure ECG oxygen saturation followed by 4-channel EEG monitoring and baseline values will be notedAfter a 4ltmin nasal oxygen cannula is placed 1 mg midazolam and 50 mcg fentanyl will be given to group I and then propofol infusion will be started at a dose of 50-100 mcgkgmin following an initial dose of 1mgkgIn group II infusion will be started at a dose of 02-07 mcgkgh after a loading dose of 1 mg midazolam 50 mcg fentanyl followed by 1 mcgkg dexmetedomidineAnesthesia depth dose adjustment will be made according to the 60-70 PSI value range in the 4-channel EEG The time to reach the adequate processing level will be recordedPatients who have reached the target depth of sedation but have hypertension will be given an additional 01 mg of glyceryl trinitrateDecreases of 25 from baseline blood pressure will be considered hypotension and will be treated with fluid boluses andor followed by IV ephedrineIn the event of apnea or desaturation airway management techniques such as patient stimulation increased oxygen supplementation chin lift chin thrust maneuver will be applied and noted
If the pulse rate drops below 50 bpm treatment with IV 05 mg atropine will be considered While the patient is being sent to the ward the patient will be asked whether he or she has had a dream and if so its content will be noted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None