Atrial FibrillationNCT05753644
The Effect of Preoperative SGB on POAF After VATS
A study testing stellate ganglion blocks and Ropivacaine in people with Atrial Fibrillation, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- stellate ganglion blocks and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Hui Ju, Dr., 861088325581, juhui11@sina.com
Kai Shen, Dr., 861088326600, shenkai11@hotmail.com
About this study
Official title: The Effect of Preoperative Stellate Ganglion Block on Postoperative Atrial Fibrillation After Video-assisted Thoracoscopic Surgeries: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation
- Being tested
- stellate ganglion blocks, Ropivacaine, Sham treatment
- Keywords
- Postoperative atrial fibrillation, stellate ganglion block
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion blocksProcedure or surgery
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.
RopivacaineDrug
Also called SGB group
5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion
Sham treatmentDrug
Also called Control group
5 mL of saline injected in the plane of the right stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: stellate ganglion blocks; Drug: Ropivacaine |
| 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. Receives: Procedure: stellate ganglion blocks; Drug: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the incidence of POAF using dynamic electrocardiogram.
Percentage of subjects who experience POAF.
Measured: within 48 hours post-surgery
Secondary outcomes (1)
Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count.
The level of inflammatory mediators.
Measured: T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start27 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhui, Peking University People's Hospital
- Investigators
- Hui Ju, Principal investigator, Peking University People's Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753644
- Sponsor's protocol ID
- SGB and POAF
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33717552Auer 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.
PubMed 16153272Koch 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.
PubMed 17062241Vidotti 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.
PubMed 31212388Kirchhof 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.
PubMed 24016492Hanna 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.
PubMed 33989382Nso 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.
PubMed 33664879Connors 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.
PubMed 29162313Leftheriotis 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.
PubMed 27353237Puente 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.
PubMed 27143533
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Stellate Ganglion Block on Postoperative Atrial Fibrillation After Video-assisted Thoracoscopic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05753644
- Acronym / sponsor ID
- SGB and POAF
- Conditions
- Atrial Fibrillation
- Keywords
- Postoperative atrial fibrillation, stellate ganglion block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGB group | Experimental | Procedure: stellate ganglion blocks, Drug: RopivacaineThe 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. |
| control group | Placebo comparator | Procedure: stellate ganglion blocks, Drug: Sham treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion blocksAt 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. | Procedure or surgery | SGB group, control group |
| RopivacaineAlso: SGB group5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion | Drug | SGB group |
| Sham treatmentAlso: Control group5 mL of saline injected in the plane of the right stellate ganglion | Drug | control group |
Primary outcome
Primary outcome is the incidence of POAF using dynamic electrocardiogram.
Time frame: within 48 hours post-surgery
Percentage of subjects who experience POAF.
1 secondary outcome
Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count.
Time frame: T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Results publication: PubMed 33717552Wang 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.
- Results publication: PubMed 16153272Auer 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.
- Results publication: PubMed 17062241Koch 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.
- Results publication: PubMed 31212388Vidotti 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.
- Results publication: PubMed 24016492Kirchhof 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.
- Results publication: PubMed 33989382Hanna 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.
- Results publication: PubMed 33664879Nso 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.
- Results publication: PubMed 29162313Connors 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.
- Results publication: PubMed 27353237Leftheriotis 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.
- Results publication: PubMed 27143533Puente 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Ju principal investigator
Peking University People's Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stellate ganglion blocks and Ropivacaine in people with Atrial Fibrillation, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Ju (861088325581, juhui11@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is the incidence of POAF using dynamic electrocardiogram. (time frame: within 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753644, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.