Background: Reducing blood pressure fluctuations during surgery is a key objective in improving patient outcomes. Although acupuncture has been suggested as a potential noninvasive intervention for blood pressure modulation, its effectiveness in reducing intraoperative fluctuations remains unclear.
Objective: This study aims to investigate whether acupuncture can help stabilize blood pressure during surgery, particularly in women undergoing laparoscopic hysterectomy-a procedure known to provoke marked hemodynamic changes during the early intraoperative phase.
Methods: This is a prospective, single-center, randomized, controlled clinical trial with a parallel group design. Forty-eight adult patients scheduled to undergo a total laparoscopic hysterectomy were eligible for this study. Participants who provide consent will be randomly assigned in a 1:1 ratio to the acupuncture or placebo groups. They will be followed up for at least 14 days to assess the safety of the intervention, general anesthesia, and surgery. Researchers will compare the differences between the highest and lowest mean blood pressures from anesthesia induction to the post-incision period as the primary endpoint. As secondary outcomes, systolic, diastolic, and mean blood pressures will be compared at each predetermined time point. The incidence of hypotension, hypertension, tachycardia, and bradycardia was counted separately. The use of remifentanil at the early stage of surgery, rate of surgical discontinuation, and length of hospital stay will be assessed as surrogate indicators of stable general anesthesia and surgical procedures. For patient-reported outcomes, the Spielberger State-Trait Anxiety Inventory and EuroQoL-5 Dimensions-5 levels will evaluate changes in anxiety and overall quality of life. This study may support the use of acupuncture as a complementary intervention to help maintain hemodynamic stability during laparoscopic hysterectomy.
Results: Recruitment began in October 2023 and is expected to continue until December 2025. The intervention and data collection procedures are proceeding without major difficulties, with a dropout rate of 11.4%. Final data analysis is scheduled for completion by March 2026, and study results are expected to be published later that year.
Conclusions: This trial will provide valuable evidence on the efficacy of acupuncture in stabilizing intraoperative blood pressure and supporting hemodynamic control during laparoscopic hysterectomy.
Clinicaltrial: The study will be conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of CHA Ilsan Medical Center (ICHA 2022-11-010, date of approval 2023-01-03). This study was registered at ClinicalTrials.gov (registration identifier: NCT05720884) and CRiS (registration identifier: KCT0009149). This publication is scheduled for December 2026, and data deposition is scheduled to occur.