NL-OMON38617已完成2 期
The analgesic efficacy of perioperative delta-9-THC (Namisol) in patients undergoing major abdominal surgery: a randomized, double blinded, placebo-controlled, parallel design - NamiSur
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is at least 18 years old on the day the informed consent form will be signed.
- •2. Patient has persistent or intermittent abdominal pain due to underlying intra-abdominal pathology.
- •3. If the patient uses concomitant analgesic medication the dosage intake is stable for at least two weeks prior to the day of screening. Stable dose intake is defined as a daily equivalent sum of intake according to medical prescription within a small deviation range as judged by the investigator.
- •4. Patient is undergoing elective, open abdominal surgery with planned use of an epidural catheter. The surgical procedure has an estimated duration of at least two hours, excluding the time to induce anesthesia.
- •5. Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
- •6. Patient is willing and able to comply with the lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other trial procedures.
- •7. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
排除标准
- •1. Patient is ineligible for the anesthesia protocol, as judged by the investigator.
- •2. Patient is undergoing (abdominal wall) surgery with mesh implantation.
- •3. Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one month prior to the day of screening.
- •4. Patient has (a history of) a medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
- •5. Patient uses amitriptyline or other concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
- •6. Patient demonstrates clinically significant deviations in the electrocardiogram (ECG) parameters at screening.
- •7. Patient is at the moment of screening diagnosed with moderate to severe renal impairment as judged by the investigator.
- •8. Patient is at the moment of screening diagnosed with moderate to severe hepatic failure as judged by the investigator.
- •9. Patient has a presence or history of major psychiatric illness as judged by the investigator.
- •10. Patient demonstrates clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •11. Patient has a history of sensitivity/idiosyncrasy to THC or diazepam, compounds related to these compounds, or to any other related drug used in the past.
- •12. Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine, MDMA, or amphetamines.
- •13. Female patient intends to conceive a child, is pregnant or breastfeeding, or does not use acceptable birth control measures including oral contraceptives, intrauterine devices or mechanical methods during the course of the study.
- •14. Patient participated in another investigational drug study within 90 days prior to the first dose and/or participated in more than 2 clinical trials in the last 365 days.
研究者
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