Vocal Cord Polyp Clinical Trial
Official title:
The Efficacy of Ultrasound Guided Superior Laryngeal Nerve Block as an Adjuvant to General Anesthesia During Vocal Cord Polypectomy by Laryngoscopy
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - To undergo direct rigid endoscopic laryngosurgery - ASA?~? Exclusion Criteria: Coagulation disorders - A history of neck surgery or an implant in the neck area - Mental illness |
Country | Name | City | State |
---|---|---|---|
China | Guizhou Provincial People's Hospital | Guiyang | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Guizhou Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The degree of severity of sore-throat at just before extubation (bucking on the ETT) | Postoperative Sore-throat was assessed at just before extubation (bucking on the ETT) using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice). | At just before extubation (bucking on the ETT). | |
Primary | The degree of severity of sore-throat at the time point of 10 minutes after extubation | Postoperative Sore-throat was assessed at 10 minutes after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) . | At the time point of 10 minutes after extubation. | |
Primary | The degree of severity of sore-throat at the time point of 1 hour after extubation | Postoperative Sore-throat was assessed at 1 hour after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) . | At the time point of 1 hour after extubation. | |
Primary | The degree of severity of sore-throat at the time point of 4 hour after extubation | Postoperative Sore-throat was assessed at 1 hour after extubation using a 4 grade scales. The degree of severity of sore throat is divided into four grades, grade 0: No sore throat, grade 1: Mild sore throat (complains of sore throat only upon inquiry) , grade 2: Moderate sore throat (complains of sore throat on his/her own), grade 3 :Severe sore throat (severe pain associated with marked change in voice) . | At the time point of 4 hour after extubation. | |
Primary | The degree of severity of cough at the time point of 30 minutes following extubation | The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia. | At the time point of 30 minutes following extubation. | |
Primary | The degree of severity of cough at the time point of 2 hours following extubation | The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia. | At the time point of 2 hours following extubation. | |
Primary | The degree of severity of cough at the time point of 4 hours following extubation | The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia. | At at the time point of 4 hours following extubation. | |
Primary | The degree of severity of cough at the time point of 24 hours following extubation | The degree of severity of cough is divided into four grades, grade 0: No cough, grade 1: Light or single cough, grade 2: Obvious to the observer, grade 3:Aphonia. | At the time point of 24 hours following extubation. | |
Primary | The degree of severity of hoarseness at the time point of 30 minutes following extubation. | The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift. | At the time point of 30 minutes following extubation. | |
Primary | The degree of severity of hoarseness at the time point of 2 hours following extubation. | The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift. | At the time point of 2 hours following extubation. | |
Primary | The degree of severity of hoarseness at the time point of 4 hours following extubation. | The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift. | At the time points of 4 hours following extubation. | |
Primary | The degree of severity of hoarseness at the time point of 24 hours following extubation. | The degree of hoarseness is divided into four grades, grade 0: None, grade 1:Noted by the patient, grade 2:More than one episode of unsustained (65 seconds) coughing, grade 3: Sustained (65 seconds) and Repetitive cough with head lift. | At the time point of 24 hours following extubation. | |
Secondary | Mean arterial pressure ( MAP) | Mean arterial pressure ( MAP) = Diastolic Pressure + 1 / 3 Pulse Pressure and normal value of 70~105 mmHg. | Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5) | |
Secondary | Heart rate (HR) | The heart rate range is 80-100 times / minutes, and the heart rate should be controlled in the normal range or ± 10%. | Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5) | |
Secondary | The 9-item quality of recovery score (QOR-9) | The 9-item quality of recovery score is a validated scale with 5 domains. These measure physical comfort, emotional state, physical independence, psychological support, and pain. The minimum value is 0 and the maximum value is 18. Higher scores indicate better results | After extubation for 30 minutes and 60 minutes. | |
Secondary | Anesthetic dosage | The operative doses of remifentanil, and shufentanyl were recorded. | During operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03410797 -
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
|
N/A |