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The Effect of Preoperative SGB on POAF After VATS

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stellate ganglion blocks
Ropivacaine
Sham treatment
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Postoperative atrial fibrillation, stellate ganglion block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SGB group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary outcome is the incidence of POAF using dynamic electrocardiogram.
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.
The level of inflammatory mediators.

Full Information

First Posted
February 12, 2023
Last Updated
April 5, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05753644
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Postoperative atrial fibrillation, stellate ganglion block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGB group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
stellate ganglion blocks
Intervention Description
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
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
SGB group
Intervention Description
5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion
Intervention Type
Drug
Intervention Name(s)
Sham treatment
Other Intervention Name(s)
Control group
Intervention Description
5 mL of saline injected in the plane of the right stellate ganglion
Primary Outcome Measure Information:
Title
Primary outcome is the incidence of POAF using dynamic electrocardiogram.
Description
Percentage of subjects who experience POAF.
Time Frame
within 48 hours post-surgery
Secondary Outcome Measure Information:
Title
Secondary outcome is the level of inflammatory mediators including IL-2, IL-6, CRP, WBC count.
Description
The level of inflammatory mediators.
Time Frame
T0: pre-induction; T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1. A cycle is 24 hours.
Other Pre-specified Outcome Measures:
Title
The third outcome is the effect of stellate nerve block on postoperative analgesia using dosage of analgesic.
Description
The effect of postoperative analgesia.
Time Frame
T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours.
Title
The fourth outcome is the effect of stellate nerve block on postoperative analgesia using NRSS score.
Description
The effect of postoperative analgesia.
Time Frame
T1: immediate after surgery; T2: 24 hours after T1; T3: 48 hours after T1; T4: 72 hours after T1. A cycle is 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Ju
Phone
861088325581
Email
juhui11@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Ju
Organizational Affiliation
Peking University People's Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Ju, Dr.
Phone
861088325581
Email
juhui11@sina.com
First Name & Middle Initial & Last Name & Degree
Kai Shen, Dr.
Phone
861088326600
Email
shenkai11@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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The Effect of Preoperative SGB on POAF After VATS

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