Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy (ASBP)

Efficacy and Safety of Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy: a Randomized Controlled, Parallel-grouped Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Total Laparoscopic Hysterectomy
• Intervention / Treatment: Device: acupuncture; Device: placebo acupuncture

Detailed Description

After sufficient explanation about the purpose and methods of this clinical study by a researcher, the subject who voluntarily decided to participate and signed a written consent will be evaluated for eligibility at the screening visit. Eligible subjects will be determined as acupuncture group and a placebo control group according to the randomization. Acupuncture treatment is performed twice, one day before surgery and the same day.

On the day of surgery, after entering the operating room, monitoring equipments (non-invasive blood pressure monitor, pulse oxygen saturation, electrocardiogram, anesthesia depth sensor, neuromuscular monitor) will be installed and vital signs including pulse rate, blood pressure, oxygen saturation are measured.

Anesthesia was induced with an anesthetic (intravenous propofol 1-2.5 mg/kg, IV), an analgesic (remifentanyl 0.2mg/hr, IVF), and a muscle relaxant (intravenous rocuronium 0.6-1.2 mg/kg). After induction of anesthesia, anesthesiologist performed tracheal intubation maintaining an appropriate depth of anesthesia (Sedline < 50). Mechanical ventilation started keeping end-tidal CO2 pressure of 25-35 mmHg). Then, an additional venous tube was secured. Additional disinfection process was performed, surgery is prepared.

With the patient in the lithotomy position and under the general anesthesia, the abdomen was prepared, painted and draped with the usual manner. The uterine elevator was inserted. Skin incision was performed and trocar was inserted. The CO2 gas was infused to make pneumoperitoneum which pressure was reached to 12mmHg. Entering into the abdominal cavity, the patient position was changed to the Trendelenburg position. And then the pelvic cavity and whole abdomen were examined. Bilateral pelvic side wall triangles were opened in parallel to infundibulopelvic ligament and ureter dissection was done. The ureteral course was identified, and then the right round ligament and ovarian ligament were coagulated with bipolar endocoagulator, cut with endoscissors. The left sided uterine ligaments were manipulated with the same method as above. The bladder flap was pushed and posterior broad ligament was mobilized. Bilateral uterine vessels were skeletonized and bilateral uterine vessels were coagulated and then cut. Circumferential colpotomy was done with unipolar scissor, and the uterus was removed transvaginally and then vaginal cuff was closed intracorporeal continuous suture. Hemostasis and ureteral peristalsis were assured and abdominal cavity was irrigated with normal saline. The subcutaneous tissue and the skin were closed layer by layer. In all processes, a qualified anesthesiologist whose clinical experience of more than 10 years will control the analgesic or anesthetic injection rate and inhalation gas concentration to maintain the appropriate blood pressure and depth of anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jee Young Lee, Dr; Phone Number: 082-31-782-3113; Email: happiade@chamc.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10414
      • Recruiting
      • Lee Jee Young
      • Contact: Jee Young Lee, Dr; Phone Number: 082-31-782-3113; Email: happiade@chamc.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture group; 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; Acupuncture of a disposable, sterilized, stainless steel needle of 0.20 mm * 30 mm size (Dongbang medical, Boryeong, Rep of Korea) will be used.
Placebo Comparator: placebo group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressures according to predetermined timepoints	systolic blood pressure, diastolic blood pressure and mean blood pressure values at entering operation room, induction time, intubation time, venous tube insertion, preparation time, skin incision, and gas inflation.	At operation time
incidence of hypotension	Total incidence count of hypotension events, determined as lower than 80% of baseline or systolic blood pressure below 90	At the end of operation moment
incidence of hypertension	Total incidence count of hypertension events, determined as systolic blood pressure over 160	At the end of operation moment
incidence of tachycardia according to predetermined timepoints	heart rate values at entering operation room, induction time, intubation time, venous tube insertion, preparation time, skin incision, and gas inflation.	At the end of operation moment
incidence of bradycardia according to predetermined timepoints	heart rate values at entering operation room, induction time, intubation time, venous tube insertion, preparation time, skin incision, and gas inflation.	At the end of operation moment
total use of remifentanil	Use of remifentanil dosage will be surrogate markers of stable general anesthesia.	At the end of operation moment
numeric rating scale for pain	numeric rating scale is a 11 point scale that defined point 0 as totally painless state, and point 10 as extreme pain as imaginable as possible.	before operation(operation date), at the end of operation moment
Spielberger's State-Trait Anxiety Inventory (STAI)	State-Trait Anxiety Inventory (STAI) consists of two categories, twenty items of questionnaire to assess state anxiety (STAI-S) and another twenty items to assess trait anxiety (STAI-T). STAI varies from a minimum score of 20 to a maximum score of 80. Lower scores means presence of less anxiety (no or low anxiety 20-37, moderate 38-44, and high anxiety 45-80).	before operation(operation date), at the end of operation moment
EuroQoL-5 Dimensions - 5 Levels (EQ-5D-5L)	The EQ-5D-5L is used to assess effects on patients' quality of life. The questionnaire consists of questions in five areas (mobility, self-care, usual activities, pain, and anxiety/depression) that ask about the patient's current state of health. Answers are provided on a 5-point Likert scale.	before operation(operation date), at the end of operation moment

Collaborators and Investigators

• Sponsor: Ilsan Cha hospital
• Investigators: Principal Investigator: Jee Young Lee, Dr, Cha Ilsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: general anesthesia; acupuncture; blood pressure fluctuation
• Other Study ID Numbers: ICICC-CT-22-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data, since researchers considered privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No