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Efficacy and Safety of Sugammadex in Renal Diseased Patients

NCT01785758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-02-07

No results posted yet for this study

Summary

The purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.

Conditions

  • Kidney Failure, Chronic
  • Neuromuscular Blockade

Interventions

DRUG

Sugammadex (4 mg/Kg)

Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium

Sponsors & Collaborators

  • Hospital General Universitario Santa Lucía

    collaborator OTHER

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Camila M Souza, MD · Federal University of São Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

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 NCT01785758 on ClinicalTrials.gov