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Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

NCT03883763 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-08

No results posted yet for this study

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).

Conditions

  • Spinal Anesthesia
  • Vascular Surgery

Interventions

DRUG

bupivacaine S75:R25 plus 8% glucose

Spinal anesthesia, 20 mg

DRUG

bupivacaine S50:R50 plus 8% glucose

Spinal anesthesia, 20 mg

Sponsors & Collaborators

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Principal Investigators

  • João B Garcia, MD/PhD · HUUFMA - Hospital Universitário da Universidade Federal do Maranhão

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883763 on ClinicalTrials.gov