Video-assisted Thoracoscopic SurgeryNCT04426097
Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracic Surgery
A study testing Cervical Vagal Blockade and Without Blockade in people with Video-assisted Thoracoscopic Surgery, run by Taipei Medical University WanFang Hospital.
Trial summary
Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery
- What is being tested?
- Cervical Vagal Blockade and Without Blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Jul 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery
Who cannot join
- Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracoscopic Surgery
Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. However, right and left side of vagus nerves both deep near the aorta or trachea respectively. To achieving the procedure may induce cough reflex by lobar traction even result vital organ damage. This study aims to apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the procedure real reduce cough reflex then previous method. We also follow up the patient's vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating if cervical vagal blockade has the potential risk involve other surrounding nerves
- Conditions
- Video-assisted Thoracoscopic Surgery
- Being tested
- Cervical Vagal Blockade, Without Blockade
- Keywords
- vagus nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Vagal BlockadeProcedure or surgery
Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml
Without BlockadeProcedure or surgery
Without Blockade
| Study group | Role | What they receive |
|---|---|---|
| Cervical Vagal Blockade | Experimental | Not described Receives: Procedure: Cervical Vagal Blockade |
| Without Blockade | Placebo comparator | Not described Receives: Procedure: Without Blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Cervical Vagal Blockade on Cough Incidence
number of coughing episodes
Measured: During the VATS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426097
- Sponsor's protocol ID
- TMU-JIRB N201803027
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katlic MR, Facktor MA. Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases. Ann Thorac Surg. 2010 Jul;90(1):240-5. doi: 10.1016/j.athoracsur.2010.02.113.
PubMed 20609784Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic surgery using regional anesthesia and vagal block and targeted sedation. J Thorac Dis. 2014 Jan;6(1):31-6. doi: 10.3978/j.issn.2072-1439.2014.01.01.
PubMed 24455173Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
PubMed 21869676Lee YJ, Chung CC, Chou HC, Lin JA. Block for uniportal video-assisted thoracoscopic surgery: an ultrasound-guided, single-penetration, double-injection approach. Br J Anaesth. 2015 Nov;115(5):792-4. doi: 10.1093/bja/aev327. No abstract available.
PubMed 26475808Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.
PubMed 22833817Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. doi: 10.2214/ajr.176.3.1760745.
PubMed 11222217Arsanious D, Khoury S, Martinez E, Nawras A, Filatoff G, Ajabnoor H, Darr U, Atallah J. Ultrasound-Guided Phrenic Nerve Block for Intractable Hiccups following Placement of Esophageal Stent for Esophageal Squamous Cell Carcinoma. Pain Physician. 2016 May;19(4):E653-6.
PubMed 27228533Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304.
PubMed 16906187Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.
PubMed 22958367
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04426097
- Acronym / sponsor ID
- TMU-JIRB N201803027
- Conditions
- Video-assisted Thoracoscopic Surgery
- Keywords
- vagus nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 11 Jun 2020 (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.
Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. However, right and left side of vagus nerves both deep near the aorta or trachea respectively. To achieving the procedure may induce cough reflex by lobar traction even result vital organ damage. This study aims to apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the procedure real reduce cough reflex then previous method. We also follow up the patient's vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating if cervical vagal blockade has the potential risk involve other surrounding nerves
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Vagal Blockade | Experimental | Procedure: Cervical Vagal Blockade |
| Without Blockade | Placebo comparator | Procedure: Without Blockade |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery
Key exclusion criteria (1 listed)
- Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia
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 |
|---|---|---|
| Cervical Vagal BlockadeCervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml | Procedure or surgery | Cervical Vagal Blockade |
| Without BlockadeWithout Blockade | Procedure or surgery | Without Blockade |
Primary outcome
Effect of Cervical Vagal Blockade on Cough Incidence
Time frame: During the VATS procedure
number of coughing episodes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 20609784Katlic MR, Facktor MA. Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases. Ann Thorac Surg. 2010 Jul;90(1):240-5. doi: 10.1016/j.athoracsur.2010.02.113.
- Background: PubMed 24455173Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic surgery using regional anesthesia and vagal block and targeted sedation. J Thorac Dis. 2014 Jan;6(1):31-6. doi: 10.3978/j.issn.2072-1439.2014.01.01.
- Background: PubMed 21869676Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
- Background: PubMed 26475808Lee YJ, Chung CC, Chou HC, Lin JA. Block for uniportal video-assisted thoracoscopic surgery: an ultrasound-guided, single-penetration, double-injection approach. Br J Anaesth. 2015 Nov;115(5):792-4. doi: 10.1093/bja/aev327. No abstract available.
- Background: PubMed 22833817Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.
- Background: PubMed 11222217Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. doi: 10.2214/ajr.176.3.1760745.
- Background: PubMed 27228533Arsanious D, Khoury S, Martinez E, Nawras A, Filatoff G, Ajabnoor H, Darr U, Atallah J. Ultrasound-Guided Phrenic Nerve Block for Intractable Hiccups following Placement of Esophageal Stent for Esophageal Squamous Cell Carcinoma. Pain Physician. 2016 May;19(4):E653-6.
- Background: PubMed 16906187Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304.
- Background: PubMed 22958367Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Vagal Blockade and Without Blockade in people with Video-assisted Thoracoscopic Surgery, run by Taipei Medical University WanFang Hospital.
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 1 inclusion and 1 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Lin Jui An, PhD (+886-66382736, ext. 1728, greenscatter1031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Cervical Vagal Blockade on Cough Incidence (time frame: During the VATS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426097, which also lists 9 linked publications.
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 11 Jun 2020.