Major Abdominal Surgery, Perioperative Anxiety
Conditions
Brief 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.
Interventions
Patients will receive three taVNS sessions, with each session lasting 60 minutes.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age: Between 18 and 85 years. 2. Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days. 3. ASA classification I-III.
Exclusion criteria
1. Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear. 2. Pre-existing bradycardia (resting heart rate \< 50 beats/min) or third-degree atrioventricular block. 3. Presence of a cardiac pacemaker or other active electronic implants. 4. A documented history of traumatic brain injury within the past 6 months. 5. Chronic pain or long-term reliance on analgesic medications. 6. Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics. 7. Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales. 8. Women who were pregnant, lactating, or planning to conceive. 9. Current enrollment in other interventional clinical trials. 10. Anticipated direct transfer to the ICU immediately following surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity and scores of perioperative anxiety | Within one month postoperatively | Perioperative anxiety severity and scores will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11) |
| Severity and scores of perioperative depression | Within one month postoperatively | Severity and scores of perioperative depression (HAMD-24) will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11) |
| Sleep Quality | Within one month postoperatively | Sleep Quality (Pittsburgh Sleep Quality Index \[PSQI\]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11) |
| Pain intensity | Within one month postoperatively | Pain Intensity (Numeric Rating Scale\[NRS\]) will be assessed at the following timepoints: 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and at the one-month postoperative follow-up (T11) |
| Incidence of postoperative delirium within the first 7 days after surgery | Within 7 days postoperatively | Incidence and severity of postoperative delirium (CAM-3D) will be evaluated at the following timepoints: 2 hours post-surgery (T6) and postoperative days 1, 2, 3, and 7 (T7-T10) |
| Frailty score | Within one month postoperatively | Frailty Score (The FRAIL Scale \[Fatigue, Resistance, Ambulation, Illness, and Loss of Weight\]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11). The FRAIL scale assesses five components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight |
| Quality of recovery | Within one month postoperatively | Quality of Recovery (Quality of Recovery Scale\[QoR-15\]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11) |
| Opioid consumption within the first 7 postoperative days | Within 7 days postoperatively | Opioid consumption within the first 7 postoperative days |
| Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation | up to 1 month | Postoperative recovery milestones: including time to first ambulation, time to first flatus, and time to first defecation |
| Length of hospital stay | up to 1 month | Length of hospital stay |
Countries
China
Contacts
CONTACTLina Yu, M.D.
Outcome results
None listed