Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block
- Registration Number
- NCT03919786
- Lead Sponsor
- Han Yuan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal saline group topical local anesthesia of pulmonary vein combined with vagus nerve block Same volume of normal saline will be administrated intervention group topical local anesthesia of pulmonary vein combined with vagus nerve block 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
- Primary Outcome Measures
Name Time Method incidence of POAF 72 hours after surgery 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.
- Secondary Outcome Measures
Name Time Method the Trail Making Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Grooved Pegboard Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Digit Span Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Number-Symbol Replacement Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Finger Tapping Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Word Fluency Test 3-6months after surgery the neuropsychological test to measure cognitive function
the Building Block Test 3-6months after surgery the neuropsychological test to measure cognitive function
Mini-Mental score examination (MMSE) 1 day before surgery(baseline)，6±1 days after surgery，one month after surgery Mini-Mental score examination \[MMSE\] used for screening of dementia
Quality of Recovery Score - 40 (QoR-40) 1 day before surgery(baseline)，1 day after surgery 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).
specific time of POAF 72 hours after surgery Specific time of POAF，such as 9：00AM，first day after surgery
incidence of other arrhythmia 15-30 days after surgery Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
Ventricular rate during POAF 72 hours after surgery Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
Incidence of postoperative delirium before discharge from PACU，twice a day every 12 hours within 3 days after surgery Confusion Assessment Method（CAM) to measure delirium
Numerical Rating Scale（NRS） before discharge from PACU，twice a day every 12 hours within 3 days after surgery Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
incidence of POAF 15-30 days after surgery Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
incidence of postoperative complications 1-30 days after surgery incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
re-admission within 30 days after surgery 1-30 days after surgery incidence and cause of re-admission
mortality within 30 days after surgery incidence and cause of mortality
hospitalization expenses up to 30 days after surgery hospitalization expenses
Postoperative length of stay up to 30 days after surgery Postoperative length of stay
admission into ICU up to 30 days after surgery incidence and length of admission into ICU
Analgesic dose up to 7 days after surgery postoperative analgesic dose converted to morphine equivalents
incidence of second operation 1 month after surgery incidence of unplanned second operation due to direct or indirect complications of the original surgery
Trial Locations
- Locations (1)
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China