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Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation

Primary Purpose

Superior Laryngeal Nerve Block

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided bilateral Thyroid Cartilage Plane Block
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Superior Laryngeal Nerve Block focused on measuring Thyroid Cartilage, Superior Laryngeal Nerve, Difficult airway, ultrasound, Awake tracheal intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Thyroid Cartilage Plane Block Group (T Group)

    the Control Group (C Group)

    Arm Description

    Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 3ml of 2% lidocaine is injected on the surface of the thyroid cartilage plate. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.

    Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the procedure.

    Outcomes

    Primary Outcome Measures

    Immediate comfort score
    The immediate comfort score upon intubation can reflect the effectiveness of superior laryngeal nerve block. A lower score indicates a better nerve block effect. 5 points for head or limb resistance movements,4points for verbal protests,3points for severe painful expressions,2points for mild painful expressions,1point for no response

    Secondary Outcome Measures

    Mean Arterial Pressure (MAP)
    Stable blood pressure indicates a good neural blockade effect.
    Heart Rate (HR)
    The smaller the heart rate fluctuations, the better the neural blockade effect.
    Ramsay Sedation Score
    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.
    The number of patients with lowered pitch
    A lowered pitch indicates a good neural blockade effect.
    The time of the block procedure
    The neural blockade procedure time reflects the ease of the operation, with a shorter time indicating a simpler neural blockade procedure.
    Record coughing in patients when the fiberoptic bronchoscope touches the glottis
    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.
    The tolerance of the tube
    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.
    Adverse reactions such as coughing and nausea/ vomiting..
    The lower the incidence of coughing, nausea, and vomiting, the better the neural blockade effect.
    Occurrences of sore throat and lowered pitch
    Pharyngeal pain and decreased vocal tone are used to assess postoperative complications of neural blockade.

    Full Information

    First Posted
    September 17, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06065475
    Brief Title
    Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation
    Official Title
    Ultrasound-guided Thyroid Cartilage Plane Block for Patients With Awake Tracheal Intubation: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 plate as an anatomical landmark. Local anesthetic is injected on the surface of the thyroid cartilage plate. 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.
    Detailed Description
    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, followed by an infusion at a rate of 0.3-0.6 μg/(kg·h) and intravenous injection of fentanyl at 0.1 μg/kg. 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). 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 plate as an anatomical landmark. 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 in-plane or 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 3ml 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 oropharyngeal, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Superior Laryngeal Nerve Block
    Keywords
    Thyroid Cartilage, Superior Laryngeal Nerve, Difficult airway, ultrasound, Awake tracheal intubation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thyroid Cartilage Plane Block Group (T Group)
    Arm Type
    Experimental
    Arm Description
    Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 3ml of 2% lidocaine is injected on the surface of the thyroid cartilage plate. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.
    Arm Title
    the Control Group (C Group)
    Arm Type
    No Intervention
    Arm Description
    Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the procedure.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ultrasound-guided bilateral Thyroid Cartilage Plane Block
    Intervention Description
    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 in-plane or 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 3ml of 2% lidocaine on the surface of the thyroid cartilage plate.
    Primary Outcome Measure Information:
    Title
    Immediate comfort score
    Description
    The immediate comfort score upon intubation can reflect the effectiveness of superior laryngeal nerve block. A lower score indicates a better nerve block effect. 5 points for head or limb resistance movements,4points for verbal protests,3points for severe painful expressions,2points for mild painful expressions,1point for no response
    Time Frame
    Upon intubation
    Secondary Outcome Measure Information:
    Title
    Mean Arterial Pressure (MAP)
    Description
    Stable blood pressure indicates a good neural blockade effect.
    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
    Title
    Heart Rate (HR)
    Description
    The smaller the heart rate fluctuations, the better the neural blockade effect.
    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
    Title
    Ramsay Sedation Score
    Description
    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.
    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
    Title
    The number of patients with lowered pitch
    Description
    A lowered pitch indicates a good neural blockade effect.
    Time Frame
    Before intubation
    Title
    The time of the block procedure
    Description
    The neural blockade procedure time reflects the ease of the operation, with a shorter time indicating a simpler neural blockade procedure.
    Time Frame
    From ultrasound probe positioning the target to completion of drug administration
    Title
    Record coughing in patients when the fiberoptic bronchoscope touches the glottis
    Description
    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.
    Time Frame
    Before intubation
    Title
    The tolerance of the tube
    Description
    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.
    Time Frame
    After successful intubation
    Title
    Adverse reactions such as coughing and nausea/ vomiting..
    Description
    The lower the incidence of coughing, nausea, and vomiting, the better the neural blockade effect.
    Time Frame
    During intubation
    Title
    Occurrences of sore throat and lowered pitch
    Description
    Pharyngeal pain and decreased vocal tone are used to assess postoperative complications of neural blockade.
    Time Frame
    Post-extubation,24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tao Shan
    Phone
    18852095135
    Email
    858727933@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ying Zhang
    Phone
    15380998716
    Email
    1070434273@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao Shan
    Organizational Affiliation
    Nanjing First Hospital, Nanjing Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    2765339
    Citation
    Wiles JR, Kelly J, Mostafa SM. Hypotension and bradycardia following superior laryngeal nerve block. Br J Anaesth. 1989 Jul;63(1):125-7. doi: 10.1093/bja/63.1.125.
    Results Reference
    background
    PubMed Identifier
    25439414
    Citation
    Canty DJ, Poon L. Superior laryngeal nerve block: an anatomical study comparing two techniques. J Clin Anesth. 2014 Nov;26(7):517-22. doi: 10.1016/j.jclinane.2014.03.005. Epub 2014 Oct 16.
    Results Reference
    background
    PubMed Identifier
    32516680
    Citation
    Fowler JG, VanEenenaam DP Jr, Johnson KN, Courtemanche CD, Strathman AJ, Reynolds JE. Single midline injection for bilateral superior laryngeal nerve block. J Clin Anesth. 2020 Nov;66:109922. doi: 10.1016/j.jclinane.2020.109922. Epub 2020 Jun 6. No abstract available. Erratum In: J Clin Anesth. 2023 Jul 29;:111195.
    Results Reference
    background

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    Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation

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