RECRUITING Early Phase 1 ClinicalTrials.gov

ENDOTRACHEAL Tube LIDOCAINE

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT07709390

Registry updated: 2026-09-03

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Description

This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to endotracheal tubes before intubation reduces airway irritation compared with standard water-based lubricant in adult patients undergoing general anesthesia. The primary objective is to determine whether lidocaine ointment decreases the incidence of coughing or bucking during emergence and extubation. Secondary objectives include evaluating the incidence and severity of postoperative sore throat and hoarseness, as well as intraoperative opioid requirements. Additional demographic and procedural data will be collected to characterize the study population and adjust for potential confounders. The study hypothesis is that 5% lidocaine ointment will reduce emergence coughing and improve postoperative airway comfort without increasing adverse outcomes.

Interventions

5% Lidocaine Ointment (Drug)
A 5% lidocaine ointment will be applied as a thin, uniform layer to the external surface of the endotracheal tube immediately before endotracheal intubation. The ointment will be applied once according to the study protocol before induction of general anesthesia.
Water-Based Lubricant (Other)
Institutional standard water-based endotracheal tube lubricant will be applied to the external surface of the endotracheal tube immediately before endotracheal intubation according to routine clinical practice before induction of general anesthesia.

Eligibility criteria

Inclusion Criteria: Adults aged 18 years and older, with an upper age limit of 90 years, scheduled for surgery requiring general anesthesia with an oral endotracheal tube. Patients undergoing general surgical procedures, including but not limited to abdominal surgeries (e.g., hernia repairs, cholecystectomy, appendectomy, bowel surgery), non-cervical spinal surgeries, craniotomies, orthopedic procedures, urologic procedures, and other procedures meeting the inclusion criteria. American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV. Patients able to provide informed consent. Exclusion Criteria: Age younger than 18 years or older than 90 years. Patients undergoing procedures requiring a specialized airway device instead of a standard oral endotracheal tube (e.g., laryngeal mask airway, double-lumen endobronchial tube). Patients with known hypersensitivity or allergy to amide local anesthetics. Patients with pre-existing sore throat, upper respiratory infection, or active cough at baseline. Patients requiring postoperative mechanical ventilation or critically ill patients requiring intensive care. Patients unable to adequately report outcomes or participate in follow-up assessments. Current smokers. Pregnant women. Prisoners.

Conditions

Emergency Coughing

Locations

The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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