Efficacy and Safety of Sugammadex in Renal Diseased Patients

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Hospital General Universitario Santa Lucía
• Treatments: Rocuronium

Criteria

Inclusion Criteria:

• age between 18 and 65 years old

• end-stage renal disease defined by clearance of creatinine < 30 ml/min

• normal renal function defined by clearance if creatinine > 90 ml/min

• candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia

Exclusion Criteria:

• pregnant and breastfeeding women

• patients with known or suspected neuromuscular disorders

• patients with hepatic disfunction

• a history of malignant hyperthermia

• allergy to narcotics, rocuronium or other medication used during general anaesthesia

• patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)