NCT03883763Unknown3 期
Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Comparison between arms from latency to T10 dermatome sensitive block
研究概览
简要总结
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Both sexes
- •Age between 18 and 80 years, inclusive
- •ASA category I or II
- •Indication of spinal anesthesia for varicose vein surgery in lower limbs with a maximum duration of 3 hours.
排除标准
- •Contraindications to spinal anesthesia
- •Hypersensitivity or intolerance to local anesthetics or to the components of formula
- •Use of any anticoagulant, regardless of type until 60 days before entering the study
- •Spinal cord injuries, peripheral neuropathies or any other neurological conditions leading to sensory and / or motor disorders
- •Dementia, mental retardation and other major cognitive changes
- •Obesity with body mass index (BMI) > 30 or difficulty in performing the puncture
- •Anatomical difficulty in the spine in the opinion of the Investigator that can make puncture difficult
- •Any previous surgical intervention of the spine
- •Tattoo at the puncture site
- •Participants with a history of alcohol or illicit drug abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition
- •Pernicious anemia
- •History of severe anaphylactic reactions or Steven-Johnson disease
- •Changes in safety exams (applicable at the time of randomization):
- •International Normalized Ratio ≥ 1.4
- •Hemoglobin < 10 g / dL
- •Platelet count <100,000 / mm3
- •Glycemia> 200 mg / dL
- •Bradyarrhythmias: heart block with clinical repercussion in the investigator's opinion
- •Maximum of eight ventricular extrasystoles per minute, evident on the ECG
- •Pregnancy or lactation
- •Any other condition that, in the opinion of the Investigator, may lead to an increased risk for the participant.
结局指标
主要结局
Comparison between arms from latency to T10 dermatome sensitive block
时间窗: 20 minutes
Time elapsed between the withdrawal of the needle at the end of the injection of the local anesthetic and the absence of response to sensorial stimuli in the region corresponding to the T10 dermatome
Comparison between arms from the duration of the sensory block
时间窗: 24 hours
Time elapsed between the withdrawal of the needle at the end of the local anesthetic injection and the presence of positive sensitivity by needle stimulation in the L5 dermatome
次要结局
- Comparison between arms from the time to reach the highest level of sensory block(1 hour)
- Comparison between arms of respiratory and cardiovascular safety(12 hours)
- Comparison between arms from the time for the 4-segment regression of the sensory block(3 hours)
- Comparison between arms from the degree of motor blockage when blocking T10 sensitive(20 minutes)
- Comparison between arms from the duration of the motor block(24 hours)
- Comparison between arms from the highest level of sensory block(3 hours)
- Comparison between arms from the occurrence of adverse events(7 days)
- Comparison between arms of cardiovascular safety(12 hours)
- Comparison between arms from the percentage of motor and sensory block failure(20 minutes)
研究者
研究点 (2)
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