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% (10 mg) - ND

SINTETICA ITALIA S.R.L.0 个研究点目标入组 120 人开始时间: 2008年6月24日最近更新: 2012年3月19日

适应症

试验速览

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•Male/female patients scheduled for short duration (less than 40 min) low abdominal or lower limbs (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

SINTETICA ITALIA S.R.L.