EUCTR2017-001285-23-NO进行中（未招募）1 期
A comparison of analgesic and respiratory effects from tapentadol versus oxycodone after laparoscopic hysterectomy. - Tapentadol study
Oslo University Hospital0 个研究点目标入组 90 人开始时间: 2017年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Women, age 18-64 years, diagnosed with a benign gynecological condition, undergoing laparoscopic, supra-cervical or total hysterectomy in general anesthesia. Informed consent. ASA classification I-III.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •BMI > 31 and/or weight <55 kg, >85 kg. Chronic pain syndromes related to other organ systems than the female reproductive tract system. Chronic opioid therapy (codeine medication allowed up to 60 mg/day) or enteral steroid therapy. Alcohol or medical abuse/addiction. Chronic obstructive pulmonary disease, untreated asthma, obstructive sleep apnea or other conditions known to predispose for respiratory depression. Neurological diagnosis with affection of respiratory system or prone to seizures.
- •Kidney or liver impairment. Biliary tract disease. Paralytic ileus. Heart failure (NYHA III-IV). Malignancy. HIV infection or other active infection. Untreated depression, severe anxiety or other psychiatric disorders independent of treatment. Cognitive failure, language barriers, hearing/visual disability or other factors which make follow-up difficult.
- •Allergy or contraindication to any of the medications used in the study. Lactose intolerance. Monoamine oxidase inhibitors or SNRI (serotonin norepinephrine reuptake inhibitors) within 14 days prior to randomization. SSRI (selective serotonin reuptake inhibitors) use is not an exclusion criterion if stable dose for at least 30 days before screening. H1-antihistamine is not an exclusion criterion unless the patient experiences somnolence as a side-effect. Benzodiazepines, barbiturates, neuroleptics, phenytoin tricyclic antidepressants, gabapentanoids, tramadol, clonidine, cimetidine, rifampicin, protease inhibitors, St John’s wort (Hypericum perforatum), macrolides and antimycotics such as ketoconazole and fluconazole.
- •Known complications to anesthesia or difficult airway. Requiring sedative medication in the postoperative observational period.
- •Patients who has participated in other clinical trials during the last 6 months is excluded to avoid confounders to the current study and for patient safety reasons.
研究者
相似试验
尚未招募
不适用
Comparative study of anaesthetic effect and pain free period of two drugs combination in spinal anesthesia in ambulatory surgeryCTRI/2020/02/023483Pramukh swami medical college
已完成
不适用
A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen.Esophageal CancerJPRN-UMIN000019186Tokyo Medical and Dental University20
已完成
不适用
A comparative investigation about analgesic effect after modified TLIP block and infiltration for lumbar spinal surgerylumbar spinal surgeryJPRN-UMIN000028681Showa university hospital76
已完成
不适用
A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease~posterior TAP block vs lateral TAP blockGynecological Laparoscopic OperationJPRN-UMIN000019314Showa university hospital
尚未招募
3 期
The use of Inhalation anaesthesia and intravenous medicine for anaesthesia in minimal invasive colorectal surgery is there any difference in the size of Optic Nerve Sheath diameter in patients positioned in head down positioCTRI/2023/10/058718Dr. Annielyn Benitta.P.J