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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04426097
Other study ID # TMU-JIRB N201803027
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date July 1, 2022

Study information

Verified date March 2020
Source Taipei Medical University WanFang Hospital
Contact Lin Jui An, PhD
Phone +886-66382736,
Email greenscatter1031@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

- Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery

Exclusion Criteria:

- Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia

Study Design


Related Conditions & MeSH terms

  • Video-assisted Thoracoscopic Surgery

Intervention

Procedure:
Cervical Vagal Blockade
Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml
Without Blockade
Without Blockade

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

References & Publications (9)

Arsanious 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. — View Citation

Chen 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. — View Citation

Chen 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. — View Citation

Dong 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. — View Citation

Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304. — View Citation

Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. — View Citation

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. — View Citation

Lee 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. — View Citation

Polverino M, Polverino F, Fasolino M, Andò 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Cervical Vagal Blockade on Cough Incidence number of coughing episodes During the VATS procedure
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