Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

NCT04903483 | Completed

• 1 other identifier: 6218-2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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)

Conditions

Anesthesia

Keywords

laser, anesthesia, bispectral index, postoperative delirium

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• cognitive functions

  through study completion, an average of 1 year

Study Arms (2)

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

OTHER

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

Other: bispectral index monitoring

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

OTHER

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

Other: bispectral index monitoring

Interventions

bispectral index monitoring OTHER

intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Also known as: depth of anesthesia

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• endolaryngeal laser surgery with target-controlled anesthesia

You may not qualify if:

• epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (2)

Department of Anaesthesiology and Intensive Therapy

Pécs, Ifjuság Str.13., 7624, Hungary

Location

PTE Department of ENT

Pécs, Hungary

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Burian Andras, MD

  University of Pecs Department of ENT

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior lecturer

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

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: May 26, 2021
• Study Start: June 18, 2021
• Primary Completion: November 25, 2024
• Study Completion: November 29, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

HU (2)