Perioperative dual-session transcutaneous auricular vagus nerve stimulation (taVNS) reduces the incidence of clinically significant postoperative sleep disturbance (POSD) after gynecologic laparoscopy compared with sham stimulation.
This protocol describes a randomized, double-blind, sham-controlled trial to test whether perioperative taVNS (two sessions: 30 min before anesthesia induction and 5 min after extubation) reduces the incidence of POSD (AIS score ≥6) on postoperative day 1. The trial plans to enroll 116 patients aged 18-65 undergoing elective gynecologic laparoscopy. The primary endpoint is the incidence of POSD on postoperative day 1, with secondary endpoints including sleep quality trajectory, anxiety/depression, recovery quality, and EEG spectral analyses.
Evidence Score
Study Evidence
Study 1. Perioperative transcutaneous auricular vagus nerve stimulation and EEG biomarkers of sleep improvement after gynecologic laparoscopy: protocol for a randomized controlled trial.
observationalHuang XQ, Zhang LX, Zheng LH, Wang Z, Yao WS, Wang QY, Wang J · Frontiers in medicine (2026)
Result:
Mechanism Graph
Limitations
- ⚠Protocol paper, no results yet; efficacy not established.
- ⚠Single-center design may limit generalizability.
- ⚠Sham stimulation may not be fully inert, potentially reducing contrast between groups.
- ⚠Primary outcome relies on self-reported AIS score, which may be subjective.
Frequently Asked Questions
What is the primary outcome of this trial?▼
The primary outcome is the incidence of clinically significant postoperative sleep disturbance (POSD) on postoperative day 1, defined as an Athens Insomnia Scale (AIS) score ≥6.
How is taVNS administered in this trial?▼
taVNS is applied to the left cymba conchae at 20 Hz with 250 μs pulse width, for two 30-minute sessions: one before anesthesia induction and one after extubation.
What is the sample size and study design?▼
This is a single-center, randomized, double-blind, sham-controlled trial with 116 patients allocated 1:1 to active taVNS or sham stimulation.
What are the secondary outcomes measured?▼
Secondary outcomes include sleep quality trajectory (AIS, actigraphy), anxiety and depression (HADS), recovery quality (QoR-15), and exploratory EEG spectral analyses.
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References
- 1.Huang XQ, Zhang LX, Zheng LH, Wang Z, Yao WS, Wang QY, Wang J. "Perioperative transcutaneous auricular vagus nerve stimulation and EEG biomarkers of sleep improvement after gynecologic laparoscopy: protocol for a randomized controlled trial.." Frontiers in medicine, 2026. PMID: 42630423 DOI: 10.3389/fmed.2026.1880911