Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery

NCT ID: NCT03919786

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-07-31

Brief Summary

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This study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who receive video-assisted thoracoscopic lobectomy .The results of the study are to assess the effects of this new intervention on the incidence,duration of atrial fibrillation and other complications including postoperative delirium after video-assisted thoracoscopic lobectomy .And reducing the burden of POAF on patients and their families, hospitals and public resources.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Intervention is not blinded to anesthesiologists and nurses participating intraoperative management.These anesthesiologists and nurses will not participate the follow-up study of this patient.Surgeons performing surgery are blinded.

Study Groups

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intervention group

Durg:0.375% Ropivacaine and 1% lidocaine

topical local anesthesia of pulmonary vein with lidocaine+ropivacaine at the beginning and the end of surgery operation.

Block vagus nerve with lidocaine+ropivacaine 1ml after exposing the pleural apex

Group Type EXPERIMENTAL

topical local anesthesia of pulmonary vein combined with vagus nerve block

Intervention Type PROCEDURE

Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation.

Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation.

Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex.

normal saline group

Same volume of normal saline will be administrated

Group Type PLACEBO_COMPARATOR

topical local anesthesia of pulmonary vein combined with vagus nerve block

Intervention Type PROCEDURE

Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation.

Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation.

Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex.

Interventions

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topical local anesthesia of pulmonary vein combined with vagus nerve block

Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation.

Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation.

Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Thoracoscopic lobectomy and bilobectomy
* ASA class I-III
* Age is greater than or equal to 50 years old
* Han Nationality, mother tongue is chinese
* The people signed informed consent

Exclusion Criteria

* history of chronic atrial arrhythmia
* sick sinus syndrome
* history of second-degree atrioventricular block
* taking class I or class III antiarrhythmic drugs or β-receptor blocker
* history of radiofrequency ablation
* hyperthyroidism
* contraindications of ropivacaine, lidocaine
* pregnancy and lactation
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Han Yuan

OTHER

Sponsor Role lead

Responsible Party

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Han Yuan

Doctor-in-charge of Anesthetist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junli Cao

Role: CONTACT

+86 15162160809

Facility Contacts

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Junli Cao

Role: primary

+86 15162160809

Other Identifiers

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XYFY2019-KL002-02

Identifier Type: -

Identifier Source: org_study_id

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