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ENDOTRACHEAL Tube LIDOCAINE (ETT LIDOCAINE)

2. september 2026 oppdatert av: Ohio State University

Application of a 5% Lidocaine Ointment to Endotracheal Tubes to Reduce Emergence Bucking: a Randomized Double-Blind Prospective 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Emergence coughing or bucking is a common complication of general anesthesia with endotracheal intubation and may result in clinically significant increases in hemodynamic stress, airway irritation, postoperative discomfort, and potential complications. Although multiple pharmacologic strategies have been evaluated to reduce emergence coughing, the effectiveness of topical lidocaine preparations applied to the endotracheal tube remains uncertain.

This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to the external surface of the endotracheal tube before intubation reduces coughing or bucking during emergence from general anesthesia compared with standard water-based endotracheal tube lubricant.

Adult patients undergoing elective surgical procedures requiring general anesthesia with oral endotracheal intubation will be randomized to receive either 5% lidocaine ointment or standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to intubation. The study will use standardized anesthetic management, double-blinding procedures, and consistent outcome assessment methods.

The primary outcome is the incidence of coughing or bucking during emergence from anesthesia, assessed from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. Secondary outcomes include the incidence and severity of postoperative sore throat and hoarseness at defined postoperative time points, as well as total intraoperative opioid administration converted to morphine milligram equivalents.

Additional demographic and procedural information, including age, sex, body mass index, American Society of Anesthesiologists physical status, airway assessment characteristics, duration of intubation, and surgical procedure type, will be collected to describe the study population and evaluate potential factors associated with outcomes.

The study aims to determine whether 5% lidocaine ointment provides a clinically useful strategy for reducing emergence-related airway irritation and improving postoperative airway comfort compared with standard endotracheal tube lubrication.

Studietype

Intervensjonell

Registrering (Antatt)

212

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Ohio
      • Columbus, Ohio, Forente stater, 43201
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Ta kontakt med:
          • Ling-Qun Hu
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and Severity of Postoperative Sore Throat
Tidsramme: 2 hours and 24 (±3) hours after extubation.
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.
2 hours and 24 (±3) hours after extubation.
Incidence and Severity of Postoperative Hoarseness
Tidsramme: 2 hours and 24 (±3) hours after extubation.
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.
2 hours and 24 (±3) hours after extubation.
Total Intraoperative Opioid Use
Tidsramme: From induction of anesthesia until endotracheal tube removal during the intraoperative period.
Total opioid administration from induction of anesthesia until extubation, converted to morphine milligram equivalents (MME) for analysis.
From induction of anesthesia until endotracheal tube removal during the intraoperative period.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ohio State University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. mai 2023

Primær fullføring (Antatt)

31. januar 2029

Studiet fullført (Antatt)

31. januar 2029

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • STUDY20260673

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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