Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 6, 2025
Date Accepted: Jul 2, 2025
Date Submitted to PubMed: Jul 2, 2025
A rationale for acupuncture in stabilizing blood pressure fluctuation during total laparoscopic hysterectomy (ASBP): study protocol for a prospective, parallel grouped, randomized clinical trial
ABSTRACT
Background/Objectives: 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. 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 and analysis: 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. We 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. Ethics and dissemination: 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 2025, and data deposition is scheduled to occur.
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