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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Deviated Nasal Septum; Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery; Rhinosinusitis With Polyps; Osteoma of the Paranasal Sinuses
• Intervention / Treatment: Device: laryngeal mask placement; Device: tracheal intubation; Drug: anesthesia of the respiratory tract with lidocaine

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Russia
  • Saint Petersburg, Russia, 197022
    • Pavlov First Saint Petersburg State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients who underwent FESS under general anesthesia

Description

Inclusion Criteria:

• general anesthesia during fess

Exclusion Criteria:

• history of mental and neurological diseases

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LMA (1); the laryngeal mask was installed intraoperatively	Device: laryngeal mask placement; intraoperative placement of a laryngeal mask
TI (2); tracheal intubation was performed intraoperatively	Device: tracheal intubation; intraoperative tracheal intubation
TIL (3); intraoperative tracheal intubation and respiratory tract anesthesia were performed	Drug: anesthesia of the respiratory tract with lidocaine; administration of 4% lidocaine during tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond agitation-sedation scale (RASS)	A 10-level scale ranges from +4 (extreme aggression) to -5 (no arousal at all). The target level for most patients is 0 (quiet alertness) or mild sedation (-1/-2).	15 minutes after waking up
The Ramsay scale	The Ramsay scale consists of 6 levels. Level 1: the patient is agitated and restless. Level 6: the patient is asleep and unresponsive. Target values for the study are levels 2-3.	15 minutes after waking up

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tracheal intubation; Laryngeal mask airway; FESS; Airway anesthesia
• Additional Relevant MeSH Terms: Organic Chemicals; Investigative Techniques; Therapeutics; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Airway Management; Intubation; Lidocaine; Intubation, Intratracheal
• Other Study ID Numbers: LM$TI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only statistical processing of an unnamed data array is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No