Sponsor study identifier
interventional
60
1 country
1
Study Start
October 15, 2023
Actual (reported)Primary Completion
December 27, 2024
Actual (reported)Study Completion
December 28, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2023
Actual (reported)October 4, 2023
Actual (reported)October 15, 2023
Actual (reported)December 27, 2024
Actual (reported)December 28, 2024
Actual (reported)quality of airway anesthesia
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.
Upon intubation
Mean Arterial Pressure (MAP)
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
Heart Rate (HR)
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
Ramsay Sedation Score
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 number of patients with lowered pitch
Before intubation
The time of the block procedure
From ultrasound probe positioning the target to completion of drug administration
All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, perform fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.
Patients in the C Group received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Patients in the C Group receive airway topical anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the vocal cord and tracheal with 5 ml 2% lidocaine respectively.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nanjing First Hospital
Nanjing, Nanjing, 210006, China
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.
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.
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.
Tao Shan
Nanjing First Hospital, Nanjing Medical University
60 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2023
First Posted
October 4, 2023
Study Start
October 15, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 27, 2024
Actual (reported)Study Completion
December 28, 2024
Actual (reported)Last Updated
February 4, 2026
Record last verified: 2026-02
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