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Trial record 4 of 10 for:    "Heart Disease" | "Ropivacaine"

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

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ClinicalTrials.gov Identifier: NCT03919786
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Brief Summary:
This study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who have thoracoscopic lobectomy or bilobectomy.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 thoracoscopic lobectomy or bilobectomy.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

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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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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 :
  1. the Trail Making Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  2. the Grooved Pegboard Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  3. the Digit Span Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  4. the Number-Symbol Replacement Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  5. the Finger Tapping Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function.

  6. the Word Fluency Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  7. the Building Block Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function

  8. 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

  9. 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).

  10. specific time of POAF [ Time Frame: 72 hours after surgery ]
    Specific time of POAF,such as 9:00AM,first day after surgery

  11. 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.

  12. Ventricular rate during POAF [ Time Frame: 72 hours after surgery ]
    Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. incidence of postoperative complications [ Time Frame: 1-30 days after surgery ]
    incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident

  20. re-admission within 30 days after surgery [ Time Frame: 1-30 days after surgery ]
    incidence and cause of re-admission

  21. mortality [ Time Frame: within 30 days after surgery ]
    incidence and cause of mortality

  22. hospitalization expenses [ Time Frame: up to 30 days after surgery ]
    hospitalization expenses

  23. Postoperative length of stay [ Time Frame: up to 30 days after surgery ]
    Postoperative length of stay

  24. admission into ICU [ Time Frame: up to 30 days after surgery ]
    incidence and length of admission into ICU

  25. Analgesic dose [ Time Frame: up to 7 days after surgery ]
    postoperative analgesic dose converted to morphine equivalents

  26. 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

  27. the Trail Making Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  28. the Grooved Pegboard Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  29. the Digit Span Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  30. the Number-Symbol Replacement Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  31. the Finger Tapping Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  32. the Word Fluency Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function

  33. the Building Block Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919786


Contacts
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Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn

Locations
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China, Jiangsu
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Sponsors and Collaborators
Han Yuan

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Responsible Party: Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03919786     History of Changes
Other Study ID Numbers: XYFY2019-KL002-02
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Yuan, Xuzhou Medical University:
postoperative atrial fibrillation
POAF
thoracic surgery
vagus nerve block
pulmonary vein
Additional relevant MeSH terms:
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Heart Diseases
Ropivacaine
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action