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NCT07849322
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Conditions: Oropharyngeal Leak Pressure, Airway Management, Postoperative Sore Throat, Cough, Hoarseness
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 48
Sponsor: Samsun University
Location: Samsun City Hospital Samsun
Summary
This prospective observational study aims to evaluate the effects of different cuff pressure levels of the Video Laryngeal Mask Airway (Video LMA) on airway safety, ventilation efficacy, and postoperative pharyngeal symptoms in patients undergoing tympanoplasty surgery. Patients are evaluated in two groups based on the measured Video LMA cuff pressure: 50 cm H2O or lower, and higher than 50 cm H2O. The primary outcome is oropharyngeal leak pressure (OLP). Secondary outcomes include the incidence and severity of postoperative pharyngeal symptoms, such as sore throat, dysphagia, and hoarseness, assessed during the first 24 hours postoperatively. Video LMA provides visual confirmation of correct anatomical position, allowing the effects of cuff pressure to be evaluated independently of device malposition.
Eligibility Criteria
Inclusion Criteria:
* Scheduled for elective tympanoplasty under general anesthesia
* American Society of Anesthesiologists (ASA) physical status I-II-III
* Aged between 18 and 75 years
* Written informed consent obtained prior to surgery
Exclusion Criteria:
* Patients who refuse to participate in the study
* Illiterate patients
* Patients unsuitable for laryngeal mask airway ventilation
* Patients with preoperative sore throat
* Patients who used NSAIDs within 24 hours prior to surgery
* Patients diagnosed with gastroesophageal reflux
* Patients with a history of oropharyngeal and/or head and neck surgery
* Patients with ASA physical status IV
* Patients with cognitive impairment or unable to cooperate
* Patients diagnosed with psychiatric disorders (schizophrenia, mania, depression, etc.)
* Patients using antipsychotic medication for longer than 4 weeks
Source: ClinicalTrials.gov (NCT07849322). StuddyBuddy aggregates publicly available trial information.