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Efficacy and safety of percutaneous vagal nerve electrical stimulation modulating the "gut-brain axis" in the intervention of postoperative complications of aortic dissection: a randomized, single-blind, placebo-controlled clinical trial

Efficacy and safety of percutaneous vagal nerve electrical stimulation modulating the "gut-brain axis" in the intervention of postoperative complications of aortic dissection: a randomized, single-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102345
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic dissection

Interventions

Experimental Group:taVNS was used to stimulate bilateral tragus or cymba conchae in addition to conventional basic treatment after AD surgery. Since this area is rich in the auricular branch of the va
Control group:Sham stimulation of scaphoid area (SF3, SF45, non-vagus nerve distribution area) was added to the routine basic treatment after AD surgery, and the parameters were the same as those of t

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with Stanford type B AD after surgery; 2. 18 years old <= age <=75 years old, male or female; 3.Signed informed consent. Patients who met all three of these criteria were eligible for the study.

Exclusion criteria

Exclusion criteria: 1.Severe hepatic and renal dysfunction (eGFR<30mL/min or ChildPughC grade); 2.Previous history of mental illness or cognitive impairment; 3.Lactating women and/or positive urine pregnancy test; 4.Heart rate <80 beats/min, blood pressure <140/80 MMHG; 5.Patients with severe infections, immune system diseases or intestinal-related diseases, or exogenous supplementation of intestinal flora; 6.Using drugs that affect autonomic function such as ß-blockers and anticholinergic drugs; 7. Skin allergy or ear infection who are not suitable for taVNS intervention 8.Those deemed by the investigators to be unfit to participate in the trial; Patients with any of the above criteria were excluded from the study.

Design outcomes

Primary

MeasureTime frame
High-sensitivity C-reactive Protein;Serum Lipopolysaccharide;Interleukin-6;Tumor Necrosis Factor-alpha;Procalcitonin;Shannon/Simpson;Diamine Oxidase Activity;Fecal Lactoferrin;Indicators related to brain-computer interface (BCI);Regional cerebral blood flow (rCBF);

Secondary

MeasureTime frame
5-Hydroxytryptamine;Brain-Derived Neurotrophic Factor;Ankle-Brachial Index;Anxiety;Health Survey;Pittsburgh Sleep Quality Index;Cardiac function;Brain Natriuretic Peptide ;Intestinal function status;Pulmonary functio;Blood gas analysis;Capillary refill time;Reactive hyperemia ;Skin temperature ;Pulse wave velocity;Carotid intima-media thickness;Vascular health index;Depression;Sleep Disorder ;Quality of Life;Activities of Daily Living ;

Countries

China

Contacts

Public ContactFan Xiaoping

Guangdong Provincial Hospital of Chinese Medicine

fanxiaoping@gzucm.edu.cn+86 138 2503 2279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026