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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07548866
Enrollment
150
Registered
2026-04-23
Start date
2026-04-01
Completion date
2027-02-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laryngeal mask airway, Tracheal intubation, Airway anesthesia, FESS

Brief summary

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

Interventions

DRUGanesthesia of the respiratory tract with lidocaine

administration of 4% lidocaine during tracheal intubation

DEVICEtracheal intubation

intraoperative tracheal intubation

DEVICElaryngeal mask placement

intraoperative placement of a laryngeal mask

Sponsors

St. Petersburg State Pavlov Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* general anesthesia during fess

Exclusion criteria

* history of mental and neurological diseases

Design outcomes

Primary

MeasureTime frameDescription
cough severity and frequencies15 minutes after waking upCoughing 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

MeasureTime frameDescription
Richmond agitation-sedation scale (RASS)15 minutes after waking upA 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).
The Ramsay scale15 minutes after waking upThe 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026