ENDOTRACHEAL Tube LIDOCAINE

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07709390
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Emergency Coughing

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43201
Ling-Qun Hu, MD
614-293-3559
Ling-Qun Hu

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