Clinical trial NCT05309174: The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy
Official title: The Efficacy of Ultrasound Guided Superior Laryngeal Nerve Block as an Adjuvant to General Anesthesia During Vocal Cord Polypectomy by Laryngoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vocal Cord Polyp
Keywords: Ultrasound Guided Superior Laryngeal Nerve Block
Vocal Cord Polypectomy by Laryngoscopy
Lead sponsor: Guizhou Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the continuous development of microsurgery, supporting laryngoscopy acoustic polyp removal has become a very mature clinical operation. The operation has small trauma, short operation time, fast turnover and needing to wake up as soon as possible, but the supporting laryngoscopy has great stimulation to the throat and great hemodynamic fluctuations. This study aims to evaluate the efficacy of ultrasound guided superior laryngeal nerve block as an adjuvant to general anesthesia during vocal cord polypectomy by laryngoscopy.

Detailed description: With the development of microsurgery, the vocal cord polypectomy by laryngoscopy has become a very mature surgery, under the laryngoscope. The surgery have some characteristics, that has a small trauma, shorter operative time, faster moving , but the strong stimulation of laryngeal surgery requires sufficient muscle relaxant condition, the greatest degree of reduce stress reaction, and waking up as soon as possible.

In the vocal cord polypectomy by laryngoscopy, the stimulation of throat often cause the nervous sympathetic excitement, including huge volatility in hemodynamics, fast heart rate, hypertension, cardiovascular serious adverse reactions such as ventricular arrhythmia, as placing the laryngoscope. Especially some patients are more obvious, who with a disease of hypertension, coronary atherosclerosis, tachycardia. It may cause myocardial ischemia and even other serious cardiovascular and cerebrovascular complications. In addition, it can also cause abnormal fluctuations in endocrine, immune and metabolism of the body, which has an important relationship with perioperative safety.

Superior laryngeal nerve block, blocking the laryngopharynx, epiglottis, tongue base, piriform recess and mucosa above the glottic fissure namely, can block the introduction of harmful stimuli and reduce pharyngeal stimulation during the perioperative period of endoscopic surgery. Bilateral superior laryngeal nerve block can reduce stress response effectively, maintaining hemodynamic stability, reducing perioperative adverse reactions and improving the safety of anesthesia. Furthermore, it can reduce the application of opioids and muscle relaxants during the operation, and shorten the time for patients to recover. Moreover, the vocal cords can be relaxed to provide good conditions for surgical operation. Accurate block of bilateral superior laryngeal nerve can also be used to provide good intraoperative and postoperative analgesia, under ultrasound guidance .

In this study, the anesthetic effect and patient status of general anesthesia and ultrasound guided superior laryngeal nerve block combined with general anesthesia were compared on the anesthesia of vocal cord polyp extraction under support laryngoscope.

The study method was to divide the subjects into experimental group and control group. The experimental group received ultrasound guided superior laryngeal nerve block combined with general anesthesia. However, the control group received all general anesthesia. The hemodynamic changes before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5minutes after extubation (T5) were recorded. The statistics of anesthetic dosage during operation were also recorded. Moreover, the investigators collect these results that the 9-item quality of recovery score (QOR-9) for 30 minutes and 60 minutes after extubation, the degree of cough immediately after extubation, 10 minutes, 1 hour and 4 hours after operation, and the degree of pharynx pain and hoarseness at 30 minutes, 2 hours, 4 hours and 24 hours after operation.

Eligibility criteria: Inclusion Criteria:

* To undergo direct rigid endoscopic laryngosurgery
* ASAⅠ～Ⅱ

Exclusion Criteria:

Coagulation disorders

* A history of neck surgery or an implant in the neck area
* Mental illness

Primary outcomes:
measure: The degree of severity of sore-throat at just before extubation (bucking on the ETT)
timeFrame: At just before extubation (bucking on the ETT).
measure: The degree of severity of sore-throat at the time point of 10 minutes after extubation
timeFrame: At the time point of 10 minutes after extubation.
measure: The degree of severity of sore-throat at the time point of 1 hour after extubation
timeFrame: At the time point of 1 hour after extubation.
measure: The degree of severity of sore-throat at the time point of 4 hour after extubation
timeFrame: At the time point of 4 hour after extubation.
measure: The degree of severity of cough at the time point of 30 minutes following extubation
timeFrame: At the time point of 30 minutes following extubation.
measure: The degree of severity of cough at the time point of 2 hours following extubation
timeFrame: At the time point of 2 hours following extubation.
measure: The degree of severity of cough at the time point of 4 hours following extubation
timeFrame: At at the time point of 4 hours following extubation.
measure: The degree of severity of cough at the time point of 24 hours following extubation
timeFrame: At the time point of 24 hours following extubation.
measure: The degree of severity of hoarseness at the time point of 30 minutes following extubation.
timeFrame: At the time point of 30 minutes following extubation.
measure: The degree of severity of hoarseness at the time point of 2 hours following extubation.
timeFrame: At the time point of 2 hours following extubation.
measure: The degree of severity of hoarseness at the time point of 4 hours following extubation.
timeFrame: At the time points of 4 hours following extubation.
measure: The degree of severity of hoarseness at the time point of 24 hours following extubation.
timeFrame: At the time point of 24 hours following extubation.
Secondary outcomes:
measure: Mean arterial pressure ( MAP)
timeFrame: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
measure: Heart rate (HR)
timeFrame: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
measure: The 9-item quality of recovery score (QOR-9)
timeFrame: After extubation for 30 minutes and 60 minutes.
measure: Anesthetic dosage
timeFrame: During operation
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
Study officials:
affiliation: Guizhou Provincial People's Hospital
name: Xiangdi Yu, MD
role: STUDY_CHAIR
References: