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COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION

30 maj 2026 uppdaterad av: Aniqa Intizar, Mayo Hospital Lahore

COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION, A RANDOMIZED CONTROLLED TRIAL

This prospective randomized controlled trial aims to compare the effectiveness of airway nerve blocks versus nebulized lidocaine in attenuating hemodynamic responses during awake fiberoptic intubation in adult patients with anticipated difficult airways. Eighty patients undergoing elective surgery requiring awake fiberoptic intubation will be randomly assigned to receive either airway nerve blocks (glossopharyngeal and transtracheal blocks with lidocaine) or nebulized lidocaine. The primary outcome will be changes in heart rate and mean arterial pressure during and after intubation. Secondary outcomes include intubation conditions, patient comfort, cough severity, intubation time, and procedure-related complications. The study aims to identify the most effective airway anesthesia technique for maintaining hemodynamic stability and improving patient tolerance during awake fiberoptic intubation.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Mayo Hospital, Lahore

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

Adults aged 18 to 65 years. American Society of Anesthesiologists (ASA) physical status I-III. Scheduled for elective surgery requiring awake fiberoptic intubation. Anticipated difficult airway. Able and willing to provide written informed consent

Exclusion Criteria:

Known allergy or hypersensitivity to lidocaine or other local anesthetics. Coagulopathy or bleeding disorders. Severe respiratory disease. Hemodynamic instability. Pregnancy. Refusal to participate in the study. Inability to cooperate with awake fiberoptic intubation or study procedures

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Nebulized Lidocaine
Participants allocated to this arm will receive airway topical anesthesia using 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Additional outcomes including intubation time, patient comfort, cough severity, and procedure-related complications will be assessed.
Läkemedel: Nebulized Lidocaine
Participants will receive 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation to provide topical airway anesthesia and suppress airway reflexes during the procedure.
Experimentell: Nerve Block
Participants allocated to this arm will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine prior to awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Secondary outcomes including intubation time, patient comfort score, cough severity, and procedure-related complications will also be assessed.
Procedur: Nerve Block
Participants will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine before awake fiberoptic intubation to provide airway anesthesia and suppress airway reflexes during the procedure.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic Intubation
Tidsram: Baseline to 5 minutes after intubation.
Change in mean arterial pressure from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
Baseline to 5 minutes after intubation.
Heart Rate Change During Awake Fiberoptic Intubation
Tidsram: Baseline to 5 minutes after intubation.
Change in heart rate from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.
Baseline to 5 minutes after intubation.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intubation Time
Tidsram: During the intubation procedure.
Time from insertion of the fiberoptic bronchoscope until confirmation of successful endotracheal tube placement.
During the intubation procedure.
Patient Comfort Score
Tidsram: Immediately after completion of awake fiberoptic intubation.
Patient comfort assessed using a standardized 5-point tolerance scale.
Immediately after completion of awake fiberoptic intubation.
Cough Severity Score
Tidsram: During the intubation procedure.
Severity of coughing during awake fiberoptic intubation assessed using a predefined cough scoring system.
During the intubation procedure.
Successful Intubation Rate
Tidsram: From intervention administration until 5 minutes after intubation.
Successful placement of an endotracheal tube without the need for rescue airway anesthesia.
From intervention administration until 5 minutes after intubation.
Procedure-Related Complications
Tidsram: From intervention administration until 5 minutes after intubation.
Incidence of adverse events including airway trauma, desaturation, allergic reactions, hoarseness, or other procedure-related complications.
From intervention administration until 5 minutes after intubation.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Mayo Hospital Lahore

Utredare

  • Huvudutredare: Aniqa Intizar, Mayo Hospital Lahore

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

28 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

30 maj 2026

Först inskickad som uppfyllde QC-kriterierna

30 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Nerve Block Intubation

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