EUCTR2014-003778-17-IT进行中（未招募）1 期
Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients - Chloroprocaine 1% - Spinal block
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- 性别
- All
入选标准
- •1. Sex, age and surgery: male/female patients, 18-80 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring = T12 metameric level of sensory block
- •2. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- •3. ASA physical status: I-III
- •4. Informed consent: signed written informed consent before inclusion in the study
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- •2. ASA physical status: IV-V
- •3. Further anaesthesia: patients expected to require further anaesthesia
- •4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
- •5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
- •6. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
- •7. Drug, alcohol: history of drug or alcohol abuse
- •8. Blood donation: blood donations in the 3 months before this study
- •9. Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
- •10. Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy)
- •11. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.
研究者
相似试验
进行中（未招募）
不适用
Spinal anaesthesia with 2 -chlopoprocaine 1% for lower limb procedures of short duration: a prospective randomized, blind, dose-finding study.EUCTR2004-004822-29-ITSINTETICA SA
已完成
不适用
Spinal anaesthesia with chloroprocain versus total intravenous anaesthesia for outpatient knee arthroscopyDiseases or conditions that indicate to an outpatient knee arthroscopyM23Internal derangement of kneeDRKS00005989Klinik für Anästhesiologie und Operative Intensivmedizin der Universitätsmedizin Mannheim50
已完成
不适用
Anesthesia for Day Care SurgeriesCTRI/2021/06/034464Self Sponsored150
已完成
不适用
Dosage finding for spinal anaesthesia using chloroprocaine 1% in patients undergoing perianal outpatient surgery.K62Other diseases of anus and rectumDRKS00007121Klinik für Anästhesiologie und Operative Intensivmedizin der Universitätsmedizin Mannheim120
进行中（未招募）
1 期
Comparisson of two epidural drugs in day-case surgeryEUCTR2015-001944-13-NLZaans Medisch Centrum175