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Completed

NCT Number: NCT06065475

Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation

The goal of this clinical trial is to investigate the clinical effectiveness and safety of superior laryngeal nerve block through surface injection of local anesthetic solution on the thyroid cartilage in patients undergoing general anesthesia with endotracheal intubation. The main questions it aims to answer are the effectiveness of ultrasound-guided Thyroid Cartilage Plane Block for superior laryngeal nerve blockadethe and the safety and ease of performance.

All patients are divided into the Thyroid Cartilage Plane Block Group (T Group) and the Control Group (C Group). Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the procedure. In the experimental T Group, ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage as an anatomical landmark. Local anesthetic is injected on the surface of the thyroid cartilage.

Compare the following parameters between the two groups: duration of the blocking procedure, Ramsay Sedation Score, patient coughing upon contact of the fiberoptic bronchoscope with the vocal cords before intubation, comfort score immediately after intubation, and tracheal tube tolerance after successful intubation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, 210006, China

About this study

Select 60 patients undergoing elective awake tracheal intubation surgery. Instruct patients to fast (no food or drink) for 8 hours before the procedure. Upon admission to the operating room, monitor patients' ECG (electrocardiogram), BP (blood pressure), and SpO2 (pulse oxygen saturation). Establish intravenous access in the upper extremities and administer normal saline solution. Administer a loading dose of dexmedetomidine at 0.5 μg/kg over 5 minutes and remifentanil 0.5μg.kg-1, followed by an infusion at a rate of 0.3-0.6 μg/(kg·h) , 0.1μg.kg-1.min-1 by micropump infusion respectively. Perform radial artery puncture and catheter placement for invasive arterial pressure monitoring. Use a computer-generated random number table to allocate patients into two groups in a 1:1 ratio. To ensure objectivity, a nurse not involved in the study prepares sealed opaque envelopes containing the group assignments. All patients are divided into the Thyroid Cartilage Plane Block Group (T Group) and the Control Group (C Group). All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray administered by an experienced anesthesiologist. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Each spray contained approximately 16 mg lidocaine. Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the vocal cord and tracheal with 5 ml 2% lidocaine respectively. In the experimental T Group, ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark.2.5 ml 2% lidocaine local anesthetic is injected on the surface of the thyroid cartilage plate. The blocking procedure is as follows: Use a Sonosite high-frequency linear array transducer (5-13 MHz, Sonosite, USA). Place the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage plate under ultrasound. Employ ultrasound-guided out-of-plane techniques to display the needle insertion path and tip. Once the needle tip contacts the upper half of the thyroid cartilage plate, inject 2.5ml of 2% lidocaine on the surface of the thyroid cartilage plate (the dosage is consistent with the commonly used local anesthetic volume for classic superior laryngeal nerve block methods in clinical practice). Subsequently, perform fiberoptic bronchoscope-guided subglottic, and tracheal surface anesthesia. After completing surface anesthesia, select an appropriate-sized tracheal tube and perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for awake tracheal intubation surgery under general anesthesia.
  • Patients with difficult airways (e.g., limited cervical spine mobility, full stomach, partial airway obstruction, craniofacial deformities or trauma, micrognathia, mouth opening <3cm, Mallampati III or IV classification) posing challenges for mask ventilation or intubation.
  • Age between 18 and 65 years.
  • Gender is not restricted.
  • ASA classification of I or II.

Exclusion criteria

  • Cardiovascular dysfunction or arterial aneurysms.
  • Mental or neurological disorders or concomitant arterial aneurysms.
  • Infection at the puncture site.
  • Allergy to local anesthetics.
  • Continuous use of antiplatelet or anticoagulant medications preoperatively.
  • Hoarseness or coughing while drinking water.
  • Bronchial asthma.
  • Participation in other clinical trials within the previous 3 months before enrollment 9.r current participation in other clinical trials.

Treatment and study plan

Ultrasound-guided bilateral Thyroid Cartilage Plane Block

Behavioral

Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Place the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage plate under ultrasound. Employ ultrasound-guided out-of-plane techniques to display the needle insertion path and tip. Once the needle tip contacts the upper half of the thyroid cartilage plate, injecting 2.5ml of 2% lidocaine on the surface of the thyroid cartilage each side.

Primary outcomes

  1. quality of airway anesthesia

    Time frame: Upon intubation

    TThe primary outcome in this trial was quality of airway anesthesia assessed on a 5-point scale,Quality of airway anesthesia was graded as: 0=no coughing or gagging in response to intubation, 1=mild coughing and/or gagging that did not hinder intubation, 2=moderate coughing and/or gagging that interfered minimally with intubation, 3=severe coughing and/or gagging that made intubation difficult and 4=very severe coughing and/or gagging that required additional local anesthetic and/or change in technique.The lower grade means a better quality of airway anesthesia.

Secondary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation

    Stable blood pressure indicates a good neural blockade effect.

  2. Heart Rate (HR)

    Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation

    The smaller the heart rate fluctuations, the better the neural blockade effect.

  3. Ramsay Sedation Score

    Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation

    The Ramsay Sedation Score is as follows: 6 points for unarousable, 5 points for slow response to stimulus, 4 points for asleep but easily aroused, 3 points for quiet and cooperative with orientation, 2 points for asleep, anxious, restless, and 1 point for asleep, agitated, and restless. Satisfactory sedation falls within 2-4 points, while oversedation is indicated by 5-6 points.

  4. The number of patients with lowered pitch

    Time frame: Before intubation

    A lowered pitch indicates a good neural blockade effect.

  5. The time of the block procedure

    Time frame: From ultrasound probe positioning the target to completion of drug administration

    The neural blockade procedure time reflects the ease of the operation, with a shorter time indicating a simpler neural blockade procedure.

  6. Record coughing in patients when the fiberoptic bronchoscope touches the glottis

    Time frame: Before intubation

    The patient's coughing upon contact of the fiberoptic bronchoscope with the vocal cords before intubation reflects the effectiveness of neural blockade. A lower degree of coughing indicates a better neural blockade effect. 1 point for no response, 2 points for mild cough, 3 points for severe cough.

  7. The tolerance of the tube

    Time frame: After successful intubation

    The tolerance of the tube reflects the patient's tolerance to awake tracheal intubation. A higher level of tolerance indicates a better neural blockade effect. 3 points for severe resistance requiring immediate general anesthesia, 2 points for restlessness and mild resistance, 1 point for cooperation.

  8. Adverse reactions such as coughing and nausea/ vomiting..

    Time frame: During intubation

    The lower the incidence of coughing, nausea, and vomiting, the better the neural blockade effect.

  9. Occurrences of sore throat and lowered pitch

    Time frame: Post-extubation,24 hours after surgery

    Pharyngeal pain and decreased vocal tone are used to assess postoperative complications of neural blockade.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Ultrasound-guided Thyroid Cartilage Plane Block for Patients With Awake Tracheal Intubation: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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