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Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

NCT ID: NCT04903483

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-18

Study Completion Date

2024-11-29

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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

SINGLE

Participants
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

Study Groups

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target-controlled infusion (propofol) with depth of anesthesia monitoring

In this group, propofol dosing is adjusted with bispectral index monitoring.

Group Type OTHER

bispectral index monitoring

Intervention Type OTHER

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

target-controlled infusion (propofol) without depth of anesthesia monitoring

In this group, propofol dosing is adjusted without bispectral index monitoring.

Group Type OTHER

bispectral index monitoring

Intervention Type OTHER

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Interventions

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bispectral index monitoring

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Intervention Type OTHER

Other Intervention Names

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depth of anesthesia

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Timea Bocskai

senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burian Andras, MD

Role: STUDY_CHAIR

University of Pecs Department of ENT

Locations

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Department of Anaesthesiology and Intensive Therapy

Pécs, Ifjuság Str.13., Hungary

Site Status

PTE Department of ENT

Pécs, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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6218-2021

Identifier Type: -

Identifier Source: org_study_id