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临床试验/NCT06040853
NCT06040853尚未招募4 期

Evaluation of Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?

Dr. Lutfi Kirdar Kartal Training and Research Hospital0 个研究点目标入组 90 人开始时间: 2023年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
主要终点
Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,

研究概览

简要总结

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG, Spo2, NIBP) will be performed when participatient are taken to the operating table without premedication. After midazolam is administered, intubation will be performed by administering 1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be administered until the skin is closed. The control group will be given 100 ml of saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the operation. The primary objectives of the study were to learn the VAS (Visual analog scale) score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours, complications and side effects (such as DVT, pulmonary embolism).

详细描述

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than 10 years of laparoscopic prostatectomy experience
  • Participant BMI(weight/height2)(kg/m2)<35
  • Participant Age>18
  • Participant Age<75

排除标准

  • Coagulation disorder,
  • Chronic renal failure,
  • Patients allergic to tranexamic acid,
  • Participant Age<18
  • Participant Age>75,
  • Participant BMI(weight/height2)(kg/m2)>35,
  • Surgeon with less than 10 years of laparoscopic prostatectomy experience,
  • Patients who had a cerebral, coronary and thromboembolic event within 6 months before the operation

研究组 & 干预措施

tranexamic group

Experimental

After intubation, intravenous 15mg/kg tranexamic acid will be given to the study group 10 minutes before the incision and 100 mg/h infusion will be administered until the skin is closed.

干预措施: Tranexamic acid intravenous administration (Drug)

placebo group

Placebo Comparator

The control group will be given intravenous 100 ml of saline

干预措施: Saline (Drug)

结局指标

主要结局

Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,

时间窗: Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score

Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,

次要结局

  • side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used(Change from baseline at 0., 1., 6. hours)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nihan Yaman Mammadov

MD, principal investigator

Dr. Lutfi Kirdar Kartal Training and Research Hospital

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