Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application

NCT07548866 | Active Not Recruiting FDA Drug FDA Device

• 1 other identifier: LM$TI
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify the advantages and disadvantages of each of the three methods of airway management during FESS.

Conditions

Rhinosinusitis With Polyps; Deviated Nasal Septum; Osteoma of the Paranasal Sinuses; Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery

Keywords

Laryngeal mask airway; Tracheal intubation; Airway anesthesia; FESS

Outcome Measures

Primary Outcomes (1)

• cough severity and frequencies

  Coughing was scored as mild (single cough), moderate (\>1 episode of un- sustained coughing lasting 5 seconds), or severe (sustained, \>5 seconds, bouts of coughing). Target values - mild cough.

  15 minutes after waking up

Secondary Outcomes (2)

• Richmond agitation-sedation scale (RASS)

  15 minutes after waking up

• The Ramsay scale

  15 minutes after waking up

Study Arms (3)

LMA (1)

the laryngeal mask was installed intraoperatively

Device: laryngeal mask placement

TI (2)

tracheal intubation was performed intraoperatively

Device: tracheal intubation

TIL (3)

intraoperative tracheal intubation and respiratory tract anesthesia were performed

Drug: anesthesia of the respiratory tract with lidocaine

Interventions

anesthesia of the respiratory tract with lidocaine DRUG

administration of 4% lidocaine during tracheal intubation

TIL (3)

tracheal intubation DEVICE

intraoperative tracheal intubation

TI (2)

laryngeal mask placement DEVICE

intraoperative placement of a laryngeal mask

LMA (1)

Eligibility Criteria

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

Study Population

adult patients who underwent FESS under general anesthesia

You may qualify if:

• general anesthesia during fess

You may not qualify if:

• history of mental and neurological diseases

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

MeSH Terms

Interventions

Lidocaine; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)