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NCT Number: NCT07548866

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • general anesthesia during fess

Exclusion criteria

  • history of mental and neurological diseases

Treatment and study plan

anesthesia of the respiratory tract with lidocaine

Drug

administration of 4% lidocaine during tracheal intubation

Tracheal intubation

Device

intraoperative tracheal intubation

laryngeal mask placement

Device

intraoperative placement of a laryngeal mask

Primary outcomes

  1. cough severity and frequencies

    Time frame: 15 minutes after waking up

    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.

Secondary outcomes

  1. Richmond agitation-sedation scale (RASS)

    Time frame: 15 minutes after waking up

    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).

  2. The Ramsay scale

    Time frame: 15 minutes after waking up

    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.

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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