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 — DRUGA 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 — OTHERInstitutional 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 OintmentParticipants 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 LubricantParticipants 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
- Ling-Qun Hu, MD6142933559
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43201 | Ling-Qun Hu |