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Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Recovery in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: A Single-Center, Prospective, Single-Arm, Non-Randomized, Open-Label Exploratory Study

Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Recovery in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: A Single-Center, Prospective, Single-Arm, Non-Randomized, Open-Label Exploratory Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110780
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Postoperative Ileus

Interventions

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Scheduled to undergo robot-assisted laparoscopic radical prostatectomy under general anesthesia. 2.American Society of Anesthesiologists (ASA) physical status classification of I to III. 3.Voluntary participation with a signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe cardiac, pulmonary, hepatic, or renal insufficiency (NYHA functional class >= III, or laboratory values of liver/kidney function exceeding twice the upper limit of normal). 2.History of abdominal/gastrointestinal surgery or chronic gastrointestinal diseases (e.g., inflammatory bowel disease, history of intestinal obstruction). 3.Uncorrected electrolyte disturbances (e.g., hypokalemia) before surgery. 4.Uncontrolled neurological disorders (e.g., epilepsy, Parkinson's disease, or myasthenia gravis). 5.Localized skin infection, lesions, or deformities in the auricular area unsuitable for electrode placement. 6.Presence of a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable electronic devices. 7.Pre-existing sick sinus syndrome, severe sinus bradycardia (heart rate < 50 bpm), or second-degree or higher atrioventricular block without a pacemaker implanted. 8.Long-term use of medications affecting gastrointestinal motility (e.g., opioids, anticholinergic drugs). 9.Presence of cognitive impairment or communication barriers that would preclude cooperation with the study procedures.

Design outcomes

Primary

MeasureTime frame
Recruitment rate;Completion rate;Protocol adherence;Incidence of adverse events;

Secondary

MeasureTime frame
Time to first flatus/defecation,;Time to the recovery of bowel sounds;Incidence of postoperative nausea and vomiting;Postoperative length of hospital stay;

Countries

China

Contacts

Public ContactMa Zhengliang

Nanjing Drum Tower Hospital

13611586781@163.com+86 136 1158 6781

Outcome results

None listed

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