Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy

NCT05720884 | Completed DMC

• 1 other identifier: ICICC-CT-22-05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to learn about efficacy of acupuncture about blood pressure fluctuation during total laparoscopic hysterectomy in patients with uterine fibroid. Participants will receive two times of acupuncture treatment before surgery and researchers will compare to see if acupuncture treatment would stabilize blood pressure fluctuation especially from induction time to post-incision moment.

Conditions

Total Laparoscopic Hysterectomy

Keywords

general anesthesia; blood pressure fluctuation; acupuncture

Outcome Measures

Primary Outcomes (1)

• changes in mean blood pressure

  the difference between the highest mean blood pressure and the lowest mean blood pressure from the induction of anesthesia to the post-incision period

  At operation time

Secondary Outcomes (9)

• blood pressures according to predetermined timepoints

  At operation time

• incidence of hypotension

  At the end of operation moment

• incidence of hypertension

  At the end of operation moment

• incidence of tachycardia according to predetermined timepoints

  At the end of operation moment

• incidence of bradycardia according to predetermined timepoints

  At the end of operation moment

Study Arms (2)

acupuncture group

EXPERIMENTAL

A total 10 acupoints of bilateral PC6, PC5, SP3, KI3, and ST36 will be chosen for the intervention group, also known as the acupuncture group. The depth of acupuncture will be varied by participant by participant. After acupuncture needles be inserted, the needles will be manually manipulated to obtain pre-determined sensation, the De Qi. Then, acupuncture will remain inserted for 20 minutes.

Device: acupuncture

placebo group

PLACEBO COMPARATOR

Ten other points, which are not official acupoints and those are not on the median nerve or peroneal nerve, will be chosen for the placebo group.

Device: placebo acupuncture

Interventions

acupuncture DEVICE

Acupuncture of a disposable, sterilized, stainless steel needle of 0.20 mm \* 30 mm size (Dongbang medical, Boryeong, Rep of Korea) will be used.

acupuncture group

placebo acupuncture DEVICE

Acupuncture of a disposable, sterilized, stainless steel needle of 0.20 mm \* 30 mm size (Dongbang medical, Boryeong, Rep of Korea) will be used but in differene location.

placebo group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between age of 19 and 69,
• American Society of Anesthesiologists (ASA) class I or II,
• required surgical removal of uterus by a gynecology specialist,
• scheduled to have total laparoscopic hysterectomy in advance.

You may not qualify if:

• expected survival within 3 months,
• emergency operation which was not scheduled in advance,
• hypertension or hypotension that can significantly interfere with the study result,
• diagnosis of arrhythmia, such as atrial fibrillation, frequent ventricular or supraventricular premature beats,
• diagnosis of heart failure or valvular disease,
• anemia of hemoglobin \< 12 g/dL,
• incapable of surgery due to hemodynamic or medical reasons other than stated above,
• incapable of receiving acupuncture treatment on determined location,
• current use of gonadotropin-releasing hormone receptor agonists,
• current use of drugs that may interfere with the result, including steroids, immunosuppressants, and psychiatric disorders,
• significant comorbidities that may interfere with the interpretation of intervention efficacy or results, such as stroke, myocardial infarction, kidney disease, dementia, or epilepsy,
• pregnant, planning to be pregnant within study period, or breastfeeding,
• previous participation in any other clinical trial within 1 month of participation, planning to participate another clinical trial within 6 months after enrollment date, or planning to participate another clinical trial on follow-up period,
• fail to write the informed consent form voluntarily,
• being deemed to be unsuitable for participation.

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (1)

Lee Jee Young

Goyang-si, Gyeonggi-do, 10414, South Korea

Location

Related Publications (1)

• Lee JY, Roh JW, Han KH, Kim MJ, Na YJ, Yun BS, Lee J. Rationale for the Use of Acupuncture to Stabilize Blood Pressure Fluctuations During Total Laparoscopic Hysterectomy: Protocol for a Pilot Parallel-Group Randomized Clinical Trial. JMIR Res Protoc. 2025 Jul 22;14:e77009. doi: 10.2196/77009.

  PMID: 40603084 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jee Young Lee, Dr

  Cha Ilsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The intervention researcher is not blinded since the researcher should perform different intervention according to the group. However, we separate the person and location to keep the blindness as robust as possible. Both the participant and the assessor are blinded and the location where intervention is performed is separate from the location where assessment is performed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: acupuncture group and placebo group

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 9, 2023
• Study Start: October 23, 2023
• Primary Completion: June 4, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)