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ENDOTRACHEAL Tube LIDOCAINE

ConditionEmergency Coughing
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOhio State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: 5% Lidocaine OintmentExperimental treatment 1 intervention
Group B: Water-Based LubricantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Coughing or Bucking During Emergence from General Anesthesia

The incidence of coughing or bucking occurring during emergence from anesthesia, defined as any cough or bucking movement from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. The outcome will be assessed by direct observation and recorded as the presence or absence of coughing/bucking and the number of bucking episodes using a standardized assessment.

Time frame
From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).

Secondary outcomes

1

Incidence and Severity of Postoperative Sore Throat

Incidence and severity of postoperative sore throat will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Moderate or severe sore throat will be considered clinically significant for analysis.

Time frame
2 hours and 24 (±3) hours after extubation.
2

Incidence and Severity of Postoperative Hoarseness

Incidence and severity of postoperative hoarseness will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Moderate or severe hoarseness will be considered clinically significant for analysis.

Time frame
2 hours and 24 (±3) hours after extubation.
3

Total Intraoperative Opioid Use

Total opioid administration from induction of anesthesia until extubation, converted to morphine milligram equivalents (MME) for analysis.

Time frame
From induction of anesthesia until endotracheal tube removal during the intraoperative period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov
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