drugset
drugset / Trial / NCT03883763

Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

NCT03883763 ↗

Phase 3 Unknown 120 enrolled Cristália Produtos Químicos Farmacêuticos Ltda.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2022-04-01
Primary completion
2023-04-30
Completion
2023-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 20 mg Intrathecal
Background Glucose Unknown 8 % Intrathecal

Indications

No indication recorded.