Acupuncture to stabilize blood pressure during laparoscopic hysterectomy
Efficacy and Safety of Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy: a Randomized Controlled, Parallel-grouped Pilot Study
This study is testing if acupuncture can help keep blood pressure steady during laparoscopic surgery for women with uterine fibroids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | All |
| Sponsor | Ilsan Cha hospital Academic / other |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT05720884 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the efficacy of acupuncture in stabilizing blood pressure fluctuations during total laparoscopic hysterectomy in patients with uterine fibroids. Participants will receive acupuncture treatment twice, once a day before surgery and again on the day of the procedure. The study will compare the blood pressure stability of those receiving acupuncture against a placebo control group during the surgical process. Vital signs will be monitored throughout the surgery to assess the impact of acupuncture on blood pressure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 69 scheduled for total laparoscopic hysterectomy due to uterine fibroids.
Not a fit: Patients with significant cardiovascular issues or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood pressure management during surgery, enhancing patient safety and outcomes.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific application during laparoscopic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Adulthood participants who were planned to have surgical removal of uterus for uterine fibroid and have expected date of total laparoscopic hysterectomy by a gynecologist were eligible. Inclusion criteria 1. between age of 19 and 69, 2. American Society of Anesthesiologists (ASA) class I or II, 3. required surgical removal of uterus by a gynecology specialist, 4. scheduled to have total laparoscopic hysterectomy in advance. Exclusion criteria 1. expected survival within 3 months, 2. emergency operation which was not scheduled in advance, 3. hypertension or hypotension that can significantly interfere with the study result, 4. diagnosis of arrhythmia, such as atrial fibrillation, frequent ventricular or supraventricular premature beats, 5. diagnosis of heart failure or valvular disease, 6. anemia of hemoglobin \< 12 g/dL, 7. incapable of surgery due to hemodynamic or medical reasons other than stated above, 8. incapable of receiving acupuncture treatment on determined location, 9. current use of gonadotropin-releasing hormone receptor agonists, 10. current use of drugs that may interfere with the result, including steroids, immunosuppressants, and psychiatric disorders, 11. significant comorbidities that may interfere with the interpretation of intervention efficacy or results, such as stroke, myocardial infarction, kidney disease, dementia, or epilepsy, 12. pregnant, planning to be pregnant within study period, or breastfeeding, 13. 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, 14. fail to write the informed consent form voluntarily, 15. being deemed to be unsuitable for participation.
Where this trial is running
Goyang-si, Gyeonggi-do
- Lee Jee Young — Goyang-si, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jee Young Lee, Dr — Cha Ilsan Medical Center
- Study coordinator: Jee Young Lee, Dr
- Email: happiade@chamc.co.kr
- Phone: 082-31-782-3113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.