Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Conditions
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Anesthesia

Intervention / Treatment
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* Other: bispectral index monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: endolaryngeal laser surgery with target-controlled anesthesia Exclusion Criteria: epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the side effects of endolaryngeal laser surgery's anesthesia with or without bispectral index monitoring in patients with smoking
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: target-controlled infusion (propofol) with depth of anesthesia monitoring<br>In this group, propofol dosing is adjusted with bispectral index monitoring. | Other: bispectral index monitoring<br>* intraoperative single-channel electroencephalography monitoring of the depth of anesthesia<br>* Other names: depth of anesthesia;|
| Other: target-controlled infusion (propofol) without depth of anesthesia monitoring<br>In this group, propofol dosing is adjusted without bispectral index monitoring. | Other: bispectral index monitoring<br>* intraoperative single-channel electroencephalography monitoring of the depth of anesthesia<br>* Other names: depth of anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, anesthesia, bispectral index, postoperative delirium