Introduction Reducing 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 analysis This 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, Spielberger’s 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 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). The publication is scheduled for December 2025. Data deposition is scheduled to occur.
Strengths and limitations of this study
Reducing blood pressure fluctuation is important during surgical process.
Considering pharmacological interactions, non-pharmacological interventions are preferable for managing blood pressure fluctuation.
Acupuncture has some potential for stabilizing blood pressure.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT05720884
Clinical ProtocolsFunding StatementThis research is supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: RS-2023-KH139140 (HF23C0097)).
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This article was a clinical research design protocol,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).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study are not available now. The publication is scheduled for December 2025. Data deposition is scheduled to occur.
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