NCT01785758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

February 3, 2013

Last Update Submit

February 5, 2013

Conditions

Kidney Failure, ChronicNeuromuscular Blockade

Keywords

complications, renal;kidney, failure;neuromuscular block, antagonism;neuromuscular block, rocuronium;safety, drugsugammadex

Outcome Measures

Primary Outcomes (1)

  • Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9

    2 hours

Secondary Outcomes (1)

  • Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8

    2 hours

Other Outcomes (1)

  • Reoccurrence of neuromuscular blockade

    24 hours

Study Arms (2)

Renal Group

EXPERIMENTAL

Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Drug: Sugammadex (4 mg/Kg)

Control group

ACTIVE COMPARATOR

Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade

Drug: Sugammadex (4 mg/Kg)

Interventions

Sugammadex (4 mg/Kg)DRUG

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

Also known as: Bridion
Control groupRenal Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

São Paulo, São Paulo, 04038002, Brazil

Location

Related Publications (3)

  • Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.

    PMID: 18653492BACKGROUND

  • Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.

    PMID: 20007792BACKGROUND

  • de Souza CM, Tardelli MA, Tedesco H, Garcia NN, Caparros MP, Alvarez-Gomez JA, de Oliveira Junior IS. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial. Eur J Anaesthesiol. 2015 Oct;32(10):681-6. doi: 10.1097/EJA.0000000000000312.

    PMID: 26225497DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Camila M Souza, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2013

First Posted

February 7, 2013

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

BR(1)