Atrial Fibrillation
Conditions
Keywords
postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve
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.
Interventions
PROCEDUREtopical 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.
Sponsors
Han Yuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| the Grooved Pegboard Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function |
| the Digit Span Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function |
| the Number-Symbol Replacement Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function |
| the Finger Tapping Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function. |
| the Word Fluency Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function |
| the Building Block Test | 1 day before surgery(baseline) | 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 | 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. |
| Ventricular rate during POAF | 72 hours after surgery | Continuous ECG recordings were made on Holter recorders for 72 hours after the operation. |
| the Trail Making Test | 1 day before surgery(baseline) | the neuropsychological test to measure cognitive function |
| 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 | 4-14 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 |
| 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 |
Countries
China
Contacts
Primary ContactJunli Cao
Outcome results
None listed