Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

November 29, 2024 updated by: Timea Bocskai, University of Pecs
Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pecs, Hungary
        • PTE Department of ENT
    • Ifjuság Str.13.
      • Pécs, Ifjuság Str.13., Hungary, 7624
        • Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • endolaryngeal laser surgery with target-controlled anesthesia

Exclusion Criteria:

  • epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
circulation
Time Frame: through study completion, an average of 1 year
blood pressure (mmHg)
through study completion, an average of 1 year
cardiac function
Time Frame: through study completion, an average of 1 year
pulse rate (beats/minute)
through study completion, an average of 1 year
oxygenization
Time Frame: through study completion, an average of 1 year
oxygen saturation (%)
through study completion, an average of 1 year
ventilation
Time Frame: through study completion, an average of 1 year
end-tidal carbon-dioxide (mmHg)
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Burian Andras, MD, University of Pecs Department of ENT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2021

Primary Completion (Actual)

November 25, 2024

Study Completion (Actual)

November 29, 2024

Study Registration Dates

First Submitted

May 22, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6218-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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