Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Anesthesia Clinical Trial

Official title:

Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903483
• Other study ID #: 6218-2021
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Pecs
• Contact: Bocskai Tímea, MD PhD
• Phone: +36 72507374
• Email: timokeri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• endolaryngeal laser surgery with target-controlled anesthesia

Exclusion Criteria:

• epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• bispectral index monitoring
intraoperative single-channel electroencephalography monitoring of the depth of anesthesia

Locations

Country	Name	City	State
Hungary	PTE Department of ENT	Pecs
Hungary	Department of Anaesthesiology and Intensive Therapy	Pécs	Ifjuság Str.13.

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulation	blood pressure (mmHg)	through study completion, an average of 1 year
Primary	cardiac function	pulse rate (beats/minute)	through study completion, an average of 1 year
Primary	oxygenization	oxygen saturation (%)	through study completion, an average of 1 year
Primary	ventilation	end-tidal carbon-dioxide (mmHg)	through study completion, an average of 1 year
Primary	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	cognitive functions	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