Vocal Cord PolypNCT05309174
The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy
A study testing USG-guided iSLN block in people with Vocal Cord Polyp, run by Guizhou Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vocal Cord Polyp
- What is being tested?
- USG-guided iSLN block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To undergo direct rigid endoscopic laryngosurgery
- ASAⅠ～Ⅱ
Who cannot join
- Coagulation disorders
- A history of neck surgery or an implant in the neck area
- Mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550003
Xiangdi Yu, MD, 008618212004663, Xiangdi_Yu@163.com
About this study
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.
Read the 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.
- Conditions
- Vocal Cord Polyp
- Being tested
- USG-guided iSLN block
- Keywords
- Ultrasound Guided Superior Laryngeal Nerve Block, Vocal Cord Polypectomy by Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG-guided iSLN blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | No intervention | Patients received general anesthesia. |
| General anesthesia combined laryngeal nerve block | Experimental | 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. Receives: Procedure: USG-guided iSLN block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At just before extubation (bucking on the ETT).
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) .
Measured: At the time point of 10 minutes after extubation.
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) .
Measured: At the time point of 1 hour after extubation.
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) .
Measured: At the time point of 4 hour after extubation.
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.
Measured: At the time point of 30 minutes following extubation.
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.
Measured: At the time point of 2 hours following extubation.
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.
Measured: At at the time point of 4 hours following extubation.
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.
Measured: At the time point of 24 hours following extubation.
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.
Measured: At the time point of 30 minutes following extubation.
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.
Measured: At the time point of 2 hours following extubation.
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.
Measured: At the time points of 4 hours following extubation.
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.
Measured: At the time point of 24 hours following extubation.
Secondary outcomes (4)
Mean arterial pressure ( MAP)
Mean arterial pressure ( MAP) = Diastolic Pressure + 1 / 3 Pulse Pressure and normal value of 70~105 mmHg.
Measured: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
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%.
Measured: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
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
Measured: After extubation for 30 minutes and 60 minutes.
Anesthetic dosage
The operative doses of remifentanil, and shufentanyl were recorded.
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Nov 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangdi Yu, MD, Study chair, Guizhou Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309174
- Sponsor's protocol ID
- 789996
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound Guided Superior Laryngeal Nerve Block as an Adjuvant to General Anesthesia During Vocal Cord Polypectomy by Laryngoscopy
- ClinicalTrials.gov ID
- NCT05309174
- Acronym / sponsor ID
- 789996
- Conditions
- Vocal Cord Polyp
- Keywords
- Ultrasound Guided Superior Laryngeal Nerve Block, Vocal Cord Polypectomy by Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | No intervention | –Patients received general anesthesia. |
| General anesthesia combined laryngeal nerve block | Experimental | Procedure: USG-guided iSLN blockGroup 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To undergo direct rigid endoscopic laryngosurgery
- ASAⅠ～Ⅱ
Key exclusion criteria (3 listed)
- Coagulation disorders
- A history of neck surgery or an implant in the neck area
- Mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG-guided iSLN blockUltrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) bilaterally with 5 ml of 0.375% ropivacaine , before general anesthesia. | Procedure or surgery | General anesthesia combined laryngeal nerve block |
Primary outcome
The degree of severity of sore-throat at just before extubation (bucking on the ETT)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time points 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.
Time frame: 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.
4 secondary outcomes
Mean arterial pressure ( MAP)
Time frame: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
Heart rate (HR)
Time frame: Before endotracheal intubation (T1), during endotracheal intubation (T2), support laryngoscope placement (T3), immediately after extubation (T4), and 5 minutes after extubation (T5)
The 9-item quality of recovery score (QOR-9)
Time frame: After extubation for 30 minutes and 60 minutes.
Anesthetic dosage
Time frame: During operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangdi Yu, MD study chair
Guizhou Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USG-guided iSLN block in people with Vocal Cord Polyp, run by Guizhou Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangdi Yu, MD (008618212004663, Xiangdi_Yu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of severity of sore-throat at just before extubation (bucking on the ETT) (time frame: At just before extubation (bucking on the ETT).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.