Clinical trial NCT05720884: Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy
Official title: Efficacy and Safety of Acupuncture for Blood Pressure Fluctuation During Total Laparoscopic Hysterectomy: a Randomized Controlled, Parallel-grouped Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Laparoscopic Hysterectomy
Keywords: general anesthesia
blood pressure fluctuation
acupuncture
Lead sponsor: Ilsan Cha hospital
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: acupuncture group and placebo group
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: changes in mean blood pressure
timeFrame: At operation time
Secondary outcomes:
measure: blood pressures according to predetermined timepoints
timeFrame: At operation time
measure: incidence of hypotension
timeFrame: At the end of operation moment
measure: incidence of hypertension
timeFrame: At the end of operation moment
measure: incidence of tachycardia according to predetermined timepoints
timeFrame: At the end of operation moment
measure: incidence of bradycardia according to predetermined timepoints
timeFrame: At the end of operation moment
measure: total use of remifentanil
timeFrame: At the end of operation moment
measure: numeric rating scale for pain
timeFrame: before operation(operation date), at the end of operation moment
measure: Spielberger's State-Trait Anxiety Inventory (STAI)
timeFrame: before operation(operation date), at the end of operation moment
measure: EuroQoL-5 Dimensions - 5 Levels (EQ-5D-5L)
timeFrame: before operation(operation date), at the end of operation moment
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Lee Jee Young
state: Gyeonggi-do
Study officials:
affiliation: Cha Ilsan Medical Center
name: Jee Young Lee, Dr
role: PRINCIPAL_INVESTIGATOR
References: