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Not Yet Recruiting NCT07709390

ENDOTRACHEAL Tube LIDOCAINE

Conditions: Emergency Coughing

Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 212
Sponsor: Ohio State University

Location: The Ohio State University Wexner Medical Center Columbus Ohio

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07709390). StuddyBuddy aggregates publicly available trial information.