The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy
Primary Purpose
Vocal Cord Polyp
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
USG-guided iSLN block
Sponsored by
About this trial
This is an interventional treatment trial for Vocal Cord Polyp focused on measuring Ultrasound Guided Superior Laryngeal Nerve Block, Vocal Cord Polypectomy by Laryngoscopy
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
Sites / Locations
- Guizhou Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
General anesthesia group
General anesthesia combined laryngeal nerve block
Arm Description
Patients received general anesthesia.
Group L received ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine, along with general anesthesia.
Outcomes
Primary Outcome Measures
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).
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) .
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) .
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) .
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Mean arterial pressure ( MAP)
Mean arterial pressure ( MAP) = Diastolic Pressure + 1 / 3 Pulse Pressure and normal value of 70~105 mmHg.
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%.
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
Anesthetic dosage
The operative doses of remifentanil, and shufentanyl were recorded.
Full Information
NCT ID
NCT05309174
First Posted
December 3, 2021
Last Updated
March 24, 2022
Sponsor
Guizhou Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05309174
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Polyp
Keywords
Ultrasound Guided Superior Laryngeal Nerve Block, Vocal Cord Polypectomy by Laryngoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia group
Arm Type
No Intervention
Arm Description
Patients received general anesthesia.
Arm Title
General anesthesia combined laryngeal nerve block
Arm Type
Experimental
Arm Description
Group L received ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine, along with general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
USG-guided iSLN block
Intervention Description
Ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine , before general anesthesia.
Primary Outcome Measure Information:
Title
The degree of severity of sore-throat at just before extubation (bucking on the ETT)
Description
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).
Time Frame
At just before extubation (bucking on the ETT).
Title
The degree of severity of sore-throat at the time point of 10 minutes after extubation
Description
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) .
Time Frame
At the time point of 10 minutes after extubation.
Title
The degree of severity of sore-throat at the time point of 1 hour after extubation
Description
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) .
Time Frame
At the time point of 1 hour after extubation.
Title
The degree of severity of sore-throat at the time point of 4 hour after extubation
Description
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) .
Time Frame
At the time point of 4 hour after extubation.
Title
The degree of severity of cough at the time point of 30 minutes following extubation
Description
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.
Time Frame
At the time point of 30 minutes following extubation.
Title
The degree of severity of cough at the time point of 2 hours following extubation
Description
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.
Time Frame
At the time point of 2 hours following extubation.
Title
The degree of severity of cough at the time point of 4 hours following extubation
Description
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.
Time Frame
At at the time point of 4 hours following extubation.
Title
The degree of severity of cough at the time point of 24 hours following extubation
Description
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.
Time Frame
At the time point of 24 hours following extubation.
Title
The degree of severity of hoarseness at the time point of 30 minutes following extubation.
Description
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.
Time Frame
At the time point of 30 minutes following extubation.
Title
The degree of severity of hoarseness at the time point of 2 hours following extubation.
Description
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.
Time Frame
At the time point of 2 hours following extubation.
Title
The degree of severity of hoarseness at the time point of 4 hours following extubation.
Description
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.
Time Frame
At the time points of 4 hours following extubation.
Title
The degree of severity of hoarseness at the time point of 24 hours following extubation.
Description
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.
Time Frame
At the time point of 24 hours following extubation.
Secondary Outcome Measure Information:
Title
Mean arterial pressure ( MAP)
Description
Mean arterial pressure ( MAP) = Diastolic Pressure + 1 / 3 Pulse Pressure and normal value of 70~105 mmHg.
Time Frame
Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
Title
Heart rate (HR)
Description
The heart rate range is 80-100 times / minutes, and the heart rate should be controlled in the normal range or ± 10%.
Time Frame
Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
Title
The 9-item quality of recovery score (QOR-9)
Description
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
Time Frame
After extubation for 30 minutes and 60 minutes.
Title
Anesthetic dosage
Description
The operative doses of remifentanil, and shufentanyl were recorded.
Time Frame
During operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangdi Yu, MD
Phone
008618212004663
Email
Xiangdi_Yu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangdi Yu, MD
Organizational Affiliation
Guizhou Provincial People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guizhou Provincial People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdi Yu, MD
Phone
008618212004663
Email
Xiangdi_Yu@163.com
12. IPD Sharing Statement
Learn more about this trial
The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy
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