The Effect of Preoperative SGB on POAF After VATS
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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
Other Names:
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| Placebo Comparator: 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. |
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: Sham treatment
5 mL of saline injected in the plane of the right stellate ganglion
Other Names:
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Outcome Measures
Primary Outcome Measures
- Primary outcome is the incidence of POAF using dynamic electrocardiogram. [within 48 hours post-surgery]
Percentage of subjects who experience POAF.
Secondary Outcome Measures
- Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count. [T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours.]
The level of inflammatory mediators.
Other Outcome Measures
- The third outcome is the effect of stellate nerve block on postoperative analgesia using dosage of analgesic. [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 effect of postoperative analgesia.
- The fourth outcome is the effect of stellate nerve block on postoperative analgesia using NRSS score. [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 effect of postoperative analgesia.
Eligibility Criteria
Criteria
Inclusion Criteria:
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1.patients undergoing elective thoracoscopic lobectomy;
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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:
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- patients with permanent atrial fibrillation, left ventricular or right ventricular pacemaker implantation or removal;
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- patients use antiarrhythmic drugs (except beta-blockers);
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3.patients use immunosuppressive drugs preoperatively;
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4.patients with active infection or sepsis;
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- patients with neurologic disorder;
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6.patients with immune deficiency syndrome.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Principal Investigator: Hui Ju, Peking University People's Hospital, Beijing, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGB and POAF