Skip to main content
OpenTrials
Completed

NCT Number: NCT04903483

Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Therapy, Pécs, Ifjuság Str.13., Hungary

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • endolaryngeal laser surgery with target-controlled anesthesia

Exclusion criteria

  • epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Treatment and study plan

bispectral index monitoring

Other

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Other names: depth of anesthesia

Primary outcomes

  1. circulation

    Time frame: through study completion, an average of 1 year

    blood pressure (mmHg)

  2. cardiac function

    Time frame: through study completion, an average of 1 year

    pulse rate (beats/minute)

  3. oxygenization

    Time frame: through study completion, an average of 1 year

    oxygen saturation (%)

  4. ventilation

    Time frame: through study completion, an average of 1 year

    end-tidal carbon-dioxide (mmHg)

  5. depth of anesthesia

    Time frame: through study completion, an average of 1 year

    bispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse

Secondary outcomes

  1. cognitive functions

    Time frame: through study completion, an average of 1 year

    cognitive functions test (Montreal Cognitive Assessment) score (number between 0-30, minimum=0, maximum=30), higher number is better

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 26, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.