Clinical trial NCT03919786: Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: postoperative atrial fibrillation
lobectomy
thoracic surgery
vagus nerve block
pulmonary myocardial sleeve
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of POAF
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: the Trail Making Test
timeFrame: 1 day before surgery(baseline)
measure: the Grooved Pegboard Test
timeFrame: 1 day before surgery(baseline)
measure: the Digit Span Test
timeFrame: 1 day before surgery(baseline)
measure: the Number-Symbol Replacement Test
timeFrame: 1 day before surgery(baseline)
measure: the Finger Tapping Test
timeFrame: 1 day before surgery(baseline)
measure: the Word Fluency Test
timeFrame: 1 day before surgery(baseline)
measure: the Building Block Test
timeFrame: 1 day before surgery(baseline)
measure: Mini-Mental score examination (MMSE)
timeFrame: 1 day before surgery(baseline)，6±1 days after surgery，one month after surgery
measure: Quality of Recovery Score - 40 (QoR-40)
timeFrame: 1 day before surgery(baseline)，1 day after surgery
measure: specific time of POAF
timeFrame: 72 hours after surgery
measure: incidence of other arrhythmia
timeFrame: 72 hours after surgery
measure: Ventricular rate during POAF
timeFrame: 72 hours after surgery
measure: Incidence of postoperative delirium
timeFrame: before discharge from PACU，twice a day every 12 hours within 3 days after surgery
measure: Numerical Rating Scale（NRS）
timeFrame: before discharge from PACU，twice a day every 12 hours within 3 days after surgery
measure: incidence of POAF
timeFrame: 4-14 days after surgery
measure: incidence of other arrhythmia
timeFrame: 4-14 days after surgery
measure: incidence of POAF
timeFrame: 15-30 days after surgery
measure: incidence of other arrhythmia
timeFrame: 15-30 days after surgery
measure: incidence of postoperative complications
timeFrame: 1-30 days after surgery
measure: re-admission within 30 days after surgery
timeFrame: 1-30 days after surgery
measure: mortality
timeFrame: within 30 days after surgery
measure: hospitalization expenses
timeFrame: up to 30 days after surgery
measure: Postoperative length of stay
timeFrame: up to 30 days after surgery
measure: admission into ICU
timeFrame: up to 30 days after surgery
measure: Analgesic dose
timeFrame: up to 7 days after surgery
measure: incidence of second operation
timeFrame: 1 month after surgery
measure: the Trail Making Test
timeFrame: 3-6months after surgery
measure: the Grooved Pegboard Test
timeFrame: 3-6months after surgery
measure: the Digit Span Test
timeFrame: 3-6months after surgery
measure: the Number-Symbol Replacement Test
timeFrame: 3-6months after surgery
measure: the Finger Tapping Test
timeFrame: 3-6months after surgery
measure: the Word Fluency Test
timeFrame: 3-6months after surgery
measure: the Building Block Test
timeFrame: 3-6months after surgery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References: