The Effect of Preoperative SGB on POAF After VATS

NCT ID: NCT05753644

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SGB group

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.

Group Type EXPERIMENTAL

stellate ganglion blocks

Intervention Type 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.

Ropivacaine

Intervention Type DRUG

5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion

control group

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.

Group Type PLACEBO_COMPARATOR

stellate ganglion blocks

Intervention Type 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.

Sham treatment

Intervention Type DRUG

5 mL of saline injected in the plane of the right stellate ganglion

Interventions

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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.

Intervention Type PROCEDURE

Ropivacaine

5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion

Intervention Type DRUG

Sham treatment

5 mL of saline injected in the plane of the right stellate ganglion

Intervention Type DRUG

Other Intervention Names

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SGB group Control group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juhui

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui Ju

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Beijing, China

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui Ju

Role: CONTACT

861088325581

Facility Contacts

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Hui Ju, Dr.

Role: primary

861088325581

Kai Shen, Dr.

Role: backup

861088326600

References

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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.

Reference Type RESULT
PMID: 33717552 (View on PubMed)

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.

Reference Type RESULT
PMID: 16153272 (View on PubMed)

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.

Reference Type RESULT
PMID: 17062241 (View on PubMed)

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.

Reference Type RESULT
PMID: 31212388 (View on PubMed)

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.

Reference Type RESULT
PMID: 24016492 (View on PubMed)

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.

Reference Type RESULT
PMID: 33989382 (View on PubMed)

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.

Reference Type RESULT
PMID: 33664879 (View on PubMed)

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.

Reference Type RESULT
PMID: 29162313 (View on PubMed)

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.

Reference Type RESULT
PMID: 27353237 (View on PubMed)

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.

Reference Type RESULT
PMID: 27143533 (View on PubMed)

Other Identifiers

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SGB and POAF

Identifier Type: -

Identifier Source: org_study_id

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