Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Other: bispectral index monitoring

• Registration Number: NCT04903483
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study First Submitted: 2021-05-22
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Study Start: 2021-06-18
• Status Verified: 2024-11
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-29
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• endolaryngeal laser surgery with target-controlled anesthesia

Exclusion Criteria

• epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
target-controlled infusion (propofol) without depth of anesthesia monitoring	bispectral index monitoring	In this group, propofol dosing is adjusted without bispectral index monitoring.
target-controlled infusion (propofol) with depth of anesthesia monitoring	bispectral index monitoring	In this group, propofol dosing is adjusted with bispectral index monitoring.

Primary Outcome Measures

Name	Time	Method
depth of anesthesia	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
cardiac function	through study completion, an average of 1 year	pulse rate (beats/minute)
ventilation	through study completion, an average of 1 year	end-tidal carbon-dioxide (mmHg)
oxygenization	through study completion, an average of 1 year	oxygen saturation (%)
circulation	through study completion, an average of 1 year	blood pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
cognitive functions	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

Trial Locations

Locations (2)

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

PTE Department of ENT; 🇭🇺 Pecs, Hungary