Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Treatments: Anesthetics; Bupivacaine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.