Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

transauricular auricular vagus nerve stimulation: Patients will receive three taVNS sessions, with each session lasting 60 minutes.

transauricular auricular vagus nerve stimulation: Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.

Study summary

It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Existing pharmacological and psychological interventions are limited by adverse effects such as respiratory depression, paralytic ileus, and poor patient compliance. While transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise as a non-invasive neuromodulation technique for chronic neuropsychiatric disorders, high-quality evidence regarding its application in anxiety-susceptible perioperative populations is still lacking. This multicenter, randomized, parallel-group, double-blind, sham-controlled trial aims to recruit 282 patients undergoing elective major abdominal surgery across four centers in Mainland China. Eligible participants will be randomized (1:1) to receive either taVNS or sham stimulation for 60 minutes daily from two days prior to surgery through the day of the operation. The primary outcome is the incidence of perioperative anxiety from the day of surgery to 72 hours postoperatively, while secondary outcomes include depression, sleep quality, pain intensity, postoperative delirium, frailty scores, quality of recovery, time to first flatus and defecation, and length of hospital stay.

Eligibility

Primary outcome measure(s)

• Incidence of perioperative anxiety — From the day of surgery through 72 hours postoperatively following the completion of the intervention
  Incidence of perioperative anxiety from the day of surgery through 72 hours postoperatively, as assessed by the 14-item Hamilton Anxiety Rating Scale (HAMA-14).

Trial sites (4)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition