Recruiting
Early Phase 1

Lidocaine Ointment

Sponsor:

Ohio State University

Code:

NCT07709390

Conditions

Emergency Coughing

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

5% Lidocaine Ointment

Water-Based Lubricant

Study Details

Brief 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.

Conditions

Emergency Coughing

Study ID

NCT07709390

Start date

May 31, 2023

Status verified date

Jul, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 5% Lidocaine Ointment

Participants randomized to this arm will receive 5% lidocaine ointment applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation. The ointment will be applied according to the study protocol before induction of general anesthesia.

active comparator: Water-Based Lubricant

Participants randomized to this arm will receive the institution's standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation. The lubricant will be applied according to routine clinical practice before induction of general anesthesia.

These entries are appropriate because both treatments are established clinical practices, with the investigational intervention being compared against an active standard-of-care comparator.

Interventions

5% Lidocaine Ointment

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

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.

Primary outcome measure

  • Incidence of Coughing or Bucking During Emergence from General Anesthesia [ Time Frame: From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction). ]

Central Contacts and Locations

Central contacts

Ling-Qun Hu, MD

6142933559lingqun.hu@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Ling-Qun Hu, MD

614-293-3559lingqun.hu@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Sep 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-09-03.