Clinical trial NCT05753644: The Effect of Preoperative SGB on POAF After VATS
Official title: The Effect of Preoperative Stellate Ganglion Block on Postoperative Atrial Fibrillation After Video-assisted Thoracoscopic Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Postoperative atrial fibrillation
stellate ganglion block
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome is the incidence of POAF using dynamic electrocardiogram.
timeFrame: within 48 hours post-surgery
Secondary outcomes:
measure: Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count.
timeFrame: T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours.
Other outcomes:
measure: The third outcome is the effect of stellate nerve block on postoperative analgesia using dosage of analgesic.
timeFrame: T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours.
measure: The fourth outcome is the effect of stellate nerve block on postoperative analgesia using NRSS score.
timeFrame: T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours.
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Beijing, China
name: Hui Ju
role: PRINCIPAL_INVESTIGATOR
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