Rationale for the Use of Acupuncture to Stabilize Blood Pressure Fluctuations During Total Laparoscopic Hysterectomy: Protocol for a Pilot Parallel-Group Randomized Clinical Trial.

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 cause 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 are 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 difference between the highest and lowest mean blood pressures from anesthesia induction to the postincision period as the primary endpoint. As secondary outcomes, systolic, diastolic, and mean blood pressures will be compared at each predetermined timepoint. The incidences of hypotension, hypertension, tachycardia, and bradycardia will be determined 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 EQ-5D-5L will be used to 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. The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board of CHA Ilsan Medical Center (ICHA 2022-11-010; date of approval: January 03, 2023).

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%. As of June 2025, a total of 35 participants have been successfully recruited and randomized. Final data analysis is scheduled for completion by March 2026, and the study results are expected to be published in December 2026.

CONCLUSIONS

This trial will provide valuable evidence on the efficacy of acupuncture for stabilizing intraoperative blood pressure and supporting hemodynamic control during laparoscopic hysterectomy.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05720884; https://clinicaltrials.gov/study/NCT05720884.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77009.