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出境医 / 临床实验 / Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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. |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | May 30, 2020 |
| Estimated Study Completion Date : | July 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: intervention group
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
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. |
|
Placebo Comparator: normal saline group
Same volume of normal saline will be administrated
|
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. |
Outcome Measures
Primary Outcome Measures :
- incidence of POAF [ Time Frame: 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 :
- the Trail Making Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- the Grooved Pegboard Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- the Digit Span Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- the Number-Symbol Replacement Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- the Finger Tapping Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function.
- the Word Fluency Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- the Building Block Test [ Time Frame: 1 day before surgery(baseline) ]the neuropsychological test to measure cognitive function
- Mini-Mental score examination (MMSE) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 72 hours after surgery ]Specific time of POAF，such as 9：00AM，first day after surgery
- incidence of other arrhythmia [ Time Frame: 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 [ Time Frame: 72 hours after surgery ]Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
- Incidence of postoperative delirium [ Time Frame: 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） [ Time Frame: 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 [ Time Frame: 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 other arrhythmia [ Time Frame: 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 POAF [ Time Frame: 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 other arrhythmia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1-30 days after surgery ]incidence and cause of re-admission
- mortality [ Time Frame: within 30 days after surgery ]incidence and cause of mortality
- hospitalization expenses [ Time Frame: up to 30 days after surgery ]hospitalization expenses
- Postoperative length of stay [ Time Frame: up to 30 days after surgery ]Postoperative length of stay
- admission into ICU [ Time Frame: up to 30 days after surgery ]incidence and length of admission into ICU
- Analgesic dose [ Time Frame: up to 7 days after surgery ]postoperative analgesic dose converted to morphine equivalents
- incidence of second operation [ Time Frame: 1 month after surgery ]incidence of unplanned second operation due to direct or indirect complications of the original surgery
- the Trail Making Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Grooved Pegboard Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Digit Span Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Number-Symbol Replacement Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Finger Tapping Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Word Fluency Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
- the Building Block Test [ Time Frame: 3-6months after surgery ]the neuropsychological test to measure cognitive function
Eligibility Criteria
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Junli Cao | +86 15162160809 | caojl0310@yahoo.com.cn |
Locations
| China, Jiangsu | |
| Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University | Recruiting |
| Xuzhou, Jiangsu, China | |
| Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn | |
Sponsors and Collaborators
Han Yuan
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 5, 2019 | ||||
| First Posted Date ICMJE | April 18, 2019 | ||||
| Last Update Posted Date | December 5, 2019 | ||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
incidence of POAF [ Time Frame: 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery | ||||
| Official Title ICMJE | 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 | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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. Primary Purpose: Prevention
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| Condition ICMJE | Atrial Fibrillation | ||||
| Intervention ICMJE | 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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
150 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 2020 | ||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03919786 | ||||
| Other Study ID Numbers ICMJE | XYFY2019-KL002-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Han Yuan, Xuzhou Medical University | ||||
| Study Sponsor ICMJE | Han Yuan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Xuzhou Medical University | ||||
| Verification Date | December 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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