鍼治療の手術中の血圧管理の役割を評価する

タイトル: Rationale of acupuncture for stabilizing blood pressure fluctuation during total laparoscopic hysterectomy (ASBP): a parallel grouped, randomized clinical trial

概要: IntroductionReducing blood pressure fluctuations during surgery is a significant goal for anesthesiologists. Acupuncture may be a non-invasive intervention to reduce blood pressure fluctuations but has not yet been studied. This study aims to determine whether acupuncture can be used to reduce blood pressure fluctuations during surgery, especially in the early stages. Methods and analysisThis is a prospective, single-center, randomized controlled clinical trial with a parallel-group design. Thirty adult patients scheduled to undergo total laparoscopic hysterectomy are eligible. Participants who consent will be randomly assigned in a 1:1 ratio to the acupuncture or placebo group. 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 pre-determined time point. Incidence of hypotension, hypertension, tachycardia, and bradycardia will be counted separately. The use of remifentanil at the early stage of surgery, the rate of surgical discontinuation, and the length of hospital stay will be assessed as surrogate indicators of stable general anesthesia and surgical procedures. For patient-reported outcomes, Spielbergers State-Trait Anxiety Inventory and EuroQoL-5 Dimensions-5 Levels will evaluate the change in anxiety and overall quality of life. Another non-pharmacological intervention may contribute to surgery by maintaining blood pressure within a stable range during the early postoperative period. Ethics and disseminationThe 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). The publication is scheduled for December 2025. Data deposition is scheduled to occur. Strengths and limitations of this studyO_LIReducing blood pressure fluctuation is important during surgical process. C_LIO_LIConsidering pharmacological interactions, non-pharmacological interventions are preferable for managing blood pressure fluctuation. C_LIO_LIAcupuncture has some potential for stabilizing blood pressure. C_LI