Effect of Cervical Vagal Blockade on Cough Incidence in N... | NCT04426097

Studies
Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracic Surgery

NCT04426097

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Video-assisted Thoracoscopic Surgery

Interventions

Cervical Vagal Blockade
Without Blockade

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Jul 1, 2021Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Mar 31, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cervical Vagal Blockade	Experimental		Procedure: Cervical Vagal Blockade
Without Blockade	Placebo Comparator		Procedure: Without Blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cervical Vagal Blockade	Procedure	Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml	Cervical Vagal Blockade

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of Cervical Vagal Blockade on Cough Incidence	number of coughing episodes	During the VATS procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Jui An, PhD	Contact	+886-66382736,	1728	greenscatter1031@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20609784	Background	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.
24455173	Background	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.