The Effect of Preoperative SGB on POAF After VATS

Atrial Fibrillation Clinical Trial

Official title:

The Effect of Preoperative Stellate Ganglion Block on Postoperative Atrial Fibrillation After Video-assisted Thoracoscopic Surgeries: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753644
• Other study ID #: SGB and POAF
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Peking University People's Hospital
• Contact: Hui Ju
• Phone: 861088325581
• Email: juhui11[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1.patients undergoing elective thoracoscopic lobectomy;

• 2.patients with one or more risk factors of POAF. According to literature, risks factors of POAF including male, aged over 65, obesity (BMI>30kg/m2), cardiac co-morbidity ( hypertension, myocardial infarction, heart failure, arrhythmia, history of valve procedure), diabetes, chronic renal insufficiency (increased creatinine level), obstructive sleep apnea syndrome (diagnosed or STOP-BANG scores =3).

Exclusion Criteria:

• 1. patients with permanent atrial fibrillation, left ventricular or right ventricular pacemaker implantation or removal;

• 2. patients use antiarrhythmic drugs (except beta-blockers);

• 3.patients use immunosuppressive drugs preoperatively;

• 4.patients with active infection or sepsis;

• 5. patients with neurologic disorder;

• 6.patients with immune deficiency syndrome.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• stellate ganglion blocks
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.

Drug:
• Ropivacaine
5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion
• Sham treatment
5 mL of saline injected in the plane of the right stellate ganglion

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. Ep — View Citation

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. — View Citation

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;1 — View Citation

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. — View Citation

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 atri — View Citation

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. — View Citation

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. — View Citation

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 Car — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	The fourth outcome is the effect of stellate nerve block on postoperative analgesia using NRSS score.	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.
Primary	Primary outcome is the incidence of POAF using dynamic electrocardiogram.	Percentage of subjects who experience POAF.	within 48 hours post-surgery
Secondary	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.