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The aim of this study is to test if stellate ganglion block can decrease the incidence of atrial fibrillation after video-assisted thoracoscopic surgery and the way it works.
Postoperative atrial fibrillation (POAF) is a common complication after video-assisted thoracoscopic surgeries. It leads to early postoperative complications, prolonged ICU stay and hospital stay, increased hospital expense and medical system burden. POAF is hard to predict and difficult to treat. The potential mechanism of POAF is not fully understood. Since early 2020, covid-19 overwhelmed globally. Chest X-rays and CT scans prescribed enormously due to screening for covid-19 infection. Lung nodules are frequently discovered and the number of video-assisted thoracoscopic procedures is surged. Prevention and new targets of treatment of POAF need to be investigated urgently. This is a double blinded, randomized controlled trial, investigating the effect of autonomic nervous system modulation on POAF. In current study, patients with one or more POAF risks, who undergo video-assisted thoracoscopic lobectomy will be enrolled and randomized into two groups. Participants in the SGB group receive stellate ganglion blocks (SGB) preoperatively, while those in the control group receive sham blocks. All the patients receive standardized anesthesia and video-assisted thoracoscopic procedures. All of participants will be monitored with portable ECG monitoring for 48 hours to detect any POAF occurrence. Cytokines including IL-2, IL-6 and inflammatory bio-markers including C-reactive protein and white blood cell count are measured before surgery, 24h and 48h after surgery. The primary outcome is the occurrence of POAF and its duration. The sample size is calculated as 191 patients per group. The presumed result will be that SGB will lower the POAF incidence and shorten the duration after video-assisted thoracoscopic surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGB group | Experimental | The subjects will accept ultrasound guided SGB in the right side of the neck in a supine position. The drug is 5 ml of 0.5% ropivacaine. |
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| control group | Placebo Comparator | The subjects will accept sham block in the right side of the neck in a supine position. A sham block is performed by subcutaneous infiltration (1 mL1% lidocaine) on the site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stellate ganglion blocks | Procedure | At the level between C6 and C7, a 25-gauge needle is inserted laterally, and the needle tip is placed posterior to the carotid artery and anterior to the longus colli muscle using an in-plane approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome is the incidence of POAF using dynamic electrocardiogram. | Percentage of subjects who experience POAF. | within 48 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count. | The level of inflammatory mediators. | T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The third outcome is the effect of stellate nerve block on postoperative analgesia using dosage of analgesic. | The effect of postoperative analgesia. | T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours. |
| The fourth outcome is the effect of stellate nerve block on postoperative analgesia using NRSS score. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Ju | Contact | 861088325581 | juhui11@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Ju | Peking University People's Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33717552 | Result | Wang H, Wang Z, Zhou M, Chen J, Yao F, Zhao L, He B. Postoperative atrial fibrillation in pneumonectomy for primary lung cancer. J Thorac Dis. 2021 Feb;13(2):789-802. doi: 10.21037/jtd-20-1717. | |
| 16153272 | Result | Auer J, Weber T, Berent R, Ng CK, Lamm G, Eber B. Risk factors of postoperative atrial fibrillation after cardiac surgery. J Card Surg. 2005 Sep-Oct;20(5):425-31. doi: 10.1111/j.1540-8191.2005.2004123.x. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | 5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion |
|
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| Sham treatment | Drug | 5 mL of saline injected in the plane of the right stellate ganglion |
|
|
The effect of postoperative analgesia. |
| T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours. |
| 17062241 | Result | Koch CG, Li L, Van Wagoner DR, Duncan AI, Gillinov AM, Blackstone EH. Red cell transfusion is associated with an increased risk for postoperative atrial fibrillation. Ann Thorac Surg. 2006 Nov;82(5):1747-56. doi: 10.1016/j.athoracsur.2006.05.045. |
| 31212388 | Result | Vidotti E, Vidotti LFK, Arruda Tavares CAG, Ferraz EDZ, Oliveira V, de Andrade AG, Cardoso JMB, Cardoso MH. Predicting postoperative atrial fibrillation after myocardial revascularization without cardiopulmonary bypass: A retrospective cohort study. J Card Surg. 2019 Jul;34(7):577-582. doi: 10.1111/jocs.14088. Epub 2019 Jun 18. |
| 24016492 | Result | Kirchhof P, Breithardt G, Camm AJ, Crijns HJ, Kuck KH, Vardas P, Wegscheider K. Improving outcomes in patients with atrial fibrillation: rationale and design of the Early treatment of Atrial fibrillation for Stroke prevention Trial. Am Heart J. 2013 Sep;166(3):442-8. doi: 10.1016/j.ahj.2013.05.015. Epub 2013 Jul 30. |
| 33989382 | Result | Hanna P, Buch E, Stavrakis S, Meyer C, Tompkins JD, Ardell JL, Shivkumar K. Neuroscientific therapies for atrial fibrillation. Cardiovasc Res. 2021 Jun 16;117(7):1732-1745. doi: 10.1093/cvr/cvab172. |
| 33664879 | Result | Nso N, Bookani KR, Metzl M, Radparvar F. Role of inflammation in atrial fibrillation: A comprehensive review of current knowledge. J Arrhythm. 2020 Dec 23;37(1):1-10. doi: 10.1002/joa3.12473. eCollection 2021 Feb. |
| 29162313 | Result | Connors CW, Craig WY, Buchanan SA, Poltak JM, Gagnon JB, Curry CS. Efficacy and Efficiency of Perioperative Stellate Ganglion Blocks in Cardiac Surgery: A Pilot Study. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e28-e30. doi: 10.1053/j.jvca.2017.10.025. Epub 2017 Oct 20. No abstract available. |
| 27353237 | Result | Leftheriotis D, Flevari P, Kossyvakis C, Katsaras D, Batistaki C, Arvaniti C, Giannopoulos G, Deftereos S, Kostopanagiotou G, Lekakis J. Acute effects of unilateral temporary stellate ganglion block on human atrial electrophysiological properties and atrial fibrillation inducibility. Heart Rhythm. 2016 Nov;13(11):2111-2117. doi: 10.1016/j.hrthm.2016.06.025. Epub 2016 Jun 21. |
| 27143533 | Result | Puente de la Vega Costa K, Gomez Perez MA, Roqueta C, Fischer L. Effects on hemodynamic variables and echocardiographic parameters after a stellate ganglion block in 15 healthy volunteers. Auton Neurosci. 2016 May;197:46-55. doi: 10.1016/j.autneu.2016.04.002. Epub 2016 Apr 16. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |