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

Atrial Fibrillation Clinical Trial

Official title:

Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery: a Double-blinded Randomized Placebo Controlled Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919786
• Other study ID #: XYFY2019-KL002-02
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 2020

Study information

• Verified date: December 2019
• Source: Xuzhou Medical University
• Contact: Junli Cao
• Phone: +86 15162160809
• Email: caojl0310[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 ß-receptor blocker

• history of radiofrequency ablation

• hyperthyroidism

• contraindications of ropivacaine, lidocaine

• pregnancy and lactation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Han Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the Trail Making Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	the Grooved Pegboard Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	the Digit Span Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	the Number-Symbol Replacement Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	the Finger Tapping Test	the neuropsychological test to measure cognitive function.	1 day before surgery(baseline)
Secondary	the Word Fluency Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	the Building Block Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Secondary	Mini-Mental score examination (MMSE)	Mini-Mental score examination [MMSE] used for screening of dementia	1 day before surgery(baseline),6±1 days after surgery,one month after surgery
Secondary	Quality of Recovery Score - 40 (QoR-40)	Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).	1 day before surgery(baseline),1 day after surgery
Secondary	specific time of POAF	Specific time of POAF,such as 9:00AM,first day after surgery	72 hours after surgery
Secondary	incidence of other arrhythmia	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	Ventricular rate during POAF	Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.	72 hours after surgery
Secondary	Incidence of postoperative delirium	Confusion Assessment Method(CAM) to measure delirium	before discharge from PACU,twice a day every 12 hours within 3 days after surgery
Secondary	Numerical Rating Scale(NRS)	Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain.	before discharge from PACU,twice a day every 12 hours within 3 days after surgery
Secondary	incidence of POAF	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	4-14 days after surgery
Secondary	incidence of other arrhythmia	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	4-14 days after surgery
Secondary	incidence of POAF	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	15-30 days after surgery
Secondary	incidence of other arrhythmia	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	15-30 days after surgery
Secondary	incidence of postoperative complications	incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident	1-30 days after surgery
Secondary	re-admission within 30 days after surgery	incidence and cause of re-admission	1-30 days after surgery
Secondary	mortality	incidence and cause of mortality	within 30 days after surgery
Secondary	hospitalization expenses	hospitalization expenses	up to 30 days after surgery
Secondary	Postoperative length of stay	Postoperative length of stay	up to 30 days after surgery
Secondary	admission into ICU	incidence and length of admission into ICU	up to 30 days after surgery
Secondary	Analgesic dose	postoperative analgesic dose converted to morphine equivalents	up to 7 days after surgery
Secondary	incidence of second operation	incidence of unplanned second operation due to direct or indirect complications of the original surgery	1 month after surgery
Secondary	the Trail Making Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Grooved Pegboard Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Digit Span Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Number-Symbol Replacement Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Finger Tapping Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Word Fluency Test	the neuropsychological test to measure cognitive function	3-6months after surgery
Secondary	the Building Block Test	the neuropsychological test to measure cognitive function	3-6months after surgery