Prospective, blind-observer, randomised clinical study to investigate and compare the efficacy of intrathecal plain solutions containing Chloroprocaine 1% (50 mg) versus Bupivacaine 0.5% (10mg)

Sintetica SA0 个研究点目标入组 0 人开始时间: 2008年11月12日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•Male/female patients scheduled for short duration (less than 40 min) low abdominal or low extremities (no more than 1/3 of cases) surgery under spinal anaesthesia,
•18-80 years old;
•18=BMI=32 kg/m2;
•ASA physical status I-II;
•Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
•Ability to co-operate with the Investigator and to comply with the requirements of the entire study;
•Signed written informed consent prior to 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Clinically relevant abnormalities at ECG (12 leads);
•Clinically relevant abnormal physical findings and clinically relevant abnormal laboratory values indicative of physical illness/es that in the opinion of the Investigator might interfere with the aim of the study
•Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients
•Ascertained or presumptive hypersensitivity to the amide type of anaesthetics
•ASA physical status III, IV or V;
•Patients requiring further anaesthesia (i.e. gas products);
•Lactating females;
•Positive pregnancy test at screening
•History of neuromuscular diseases to the lower extremities,
•Contraindication to spinal anaesthesia;
•Participation in the evaluation of any drug within 3 months prior to screening;
•Blood donations during the 3 months prior to this study;
•History of drug, or alcohol abuse

发起方