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

NCT03919786 | Unknown

• 1 other identifier: XYFY2019-KL002-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

postoperative atrial fibrillation; lobectomy; thoracic surgery; vagus nerve block; pulmonary myocardial sleeve

Outcome Measures

Primary Outcomes (1)

• incidence of POAF

  Continuous ECG recordings were made on Holter recorders for 72 hours after the operation. Arrhythmia detection were done automatically by template matching. The decisions made automatically by the computer were reviewed and corrected by an experienced technician and then by a cardiologist.

  72 hours after surgery

Secondary Outcomes (33)

• the Trail Making Test

  1 day before surgery(baseline)

• the Grooved Pegboard Test

  1 day before surgery(baseline)

• the Digit Span Test

  1 day before surgery(baseline)

• the Number-Symbol Replacement Test

  1 day before surgery(baseline)

• the Finger Tapping Test

  1 day before surgery(baseline)

Study Arms (2)

intervention group

EXPERIMENTAL

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

Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block

normal saline group

PLACEBO COMPARATOR

Same volume of normal saline will be administrated

Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block

Interventions

topical local anesthesia of pulmonary vein combined with vagus nerve block 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.

intervention group; normal saline group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Han Yuan: lead

Study Sites (1)

Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Junli Cao

CONTACT

+86 15162160809; caojl0310@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor-in-charge of Anesthetist

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 18, 2019
• Study Start: April 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 1, 2020
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

CN (1)