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Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04903483
Enrollment
50
Registered
2021-05-26
Start date
2021-06-18
Completion date
2024-11-29
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

laser, anesthesia, bispectral index, postoperative delirium

Brief summary

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

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.

Interventions

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

the side effects of endolaryngeal laser surgery's anesthesia with or without bispectral index monitoring in patients with smoking

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* endolaryngeal laser surgery with target-controlled anesthesia

Exclusion criteria

* epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Design outcomes

Primary

MeasureTime frameDescription
circulationthrough study completion, an average of 1 yearblood pressure (mmHg)
cardiac functionthrough study completion, an average of 1 yearpulse rate (beats/minute)
oxygenizationthrough study completion, an average of 1 yearoxygen saturation (%)
ventilationthrough study completion, an average of 1 yearend-tidal carbon-dioxide (mmHg)
depth of anesthesiathrough study completion, an average of 1 yearbispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse

Secondary

MeasureTime frameDescription
cognitive functionsthrough study completion, an average of 1 yearcognitive functions test (Montreal Cognitive Assessment) score (number between 0-30, minimum=0, maximum=30), higher number is better

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026