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Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)
All participants are informed about the investigation and are signed the Informed Consent before anesthesia. The study takes place at the Department of Otorhinolaryngology, University of Pecs, Hungary. Between June 2021 and May 2022 ASA I or II patients aged 18-65 years, scheduled for elective endolaryngeal laser surgery with TCI (target-controlled infusion, propofol). Exclusion criteria are epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease. Participants are randomized to two anesthetic groups, anesthesia with or without bispectral index monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| target-controlled infusion (propofol) with depth of anesthesia monitoring | Other | In this group, propofol dosing is adjusted with bispectral index monitoring. |
|
| target-controlled infusion (propofol) without depth of anesthesia monitoring | Other | In this group, propofol dosing is adjusted without bispectral index monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bispectral index monitoring | Other | intraoperative single-channel electroencephalography monitoring of the depth of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| circulation | blood pressure (mmHg) | through study completion, an average of 1 year |
| cardiac function | pulse rate (beats/minute) | through study completion, an average of 1 year |
| oxygenization | oxygen saturation (%) | through study completion, an average of 1 year |
| ventilation | end-tidal carbon-dioxide (mmHg) | through study completion, an average of 1 year |
| depth of anesthesia | bispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive functions | cognitive functions test (Montreal Cognitive Assessment) score (number between 0-30, minimum=0, maximum=30), higher number is better | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burian Andras, MD | University of Pecs Department of ENT | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Therapy | Pécs | Ifjuság Str.13. | 7624 | Hungary | ||
| PTE Department of ENT |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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the side effects of endolaryngeal laser surgery's anesthesia with or without bispectral index monitoring in patients with smoking
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anesthesia with target-controlled infusion (propofol) with or without the depth of anesthesia (bispectral index) monitoring and evaluation of vital parameters, side effects, and postoperative delirium
|
| Pécs |
| Hungary |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |