Rationale for the Use of Acupuncture to Stabilize Blood Pressure Fluctuations During Total Laparoscopic Hysterectomy: Protocol for a Pilot Parallel-Group Randomized Clinical Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.036 | 0.036 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.009 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.010 |
| Insufficient payload (model declined to judge) | 0.071 | 0.015 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".