NCT01828385

Brief Summary

The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

April 5, 2013

Last Update Submit

January 17, 2015

Conditions

Neuromuscular Blockade

Keywords

Physiological Effects of DrugsRocuroniumSugammadex sodiumMagnesiumMolecular Mechanisms of Pharmacological ActionNeuromuscular block, antagonismPharmacologic Actions

Outcome Measures

Primary Outcomes (1)

  • Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate

    When T1 reached 25%, a single bolus dose of sugammadex 2 mg.kg-1 was administered to facilitate the recovery. The times to reach a TOF ratio of 0.9 and T1 height value were measured.

    3 hours

Secondary Outcomes (1)

  • Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room

    4 hours

Study Arms (2)

Group Mg

EXPERIMENTAL

Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1

Drug: Magnesium Sulfate

Group C

ACTIVE COMPARATOR

Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1

Drug: Saline

Interventions

Magnesium SulfateDRUG

Magnesium sulfate + rocuronium + sugammadex

Group Mg
SalineDRUG

Saline + rocuronium + sugammadex

Group C

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • ASA physical status 1 or 2
  • weight BMI 18.5-24.9
  • otorhinolaryngological surgeries

You may not qualify if:

  • major surgery associated with massive blood loss or fluid replacement
  • any known allergy to magnesium sulphate or any other study drugs
  • pregnant
  • anatomical malformations expected to result in a difficult intubation;
  • known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction
  • administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications)
  • hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil

Location

Related Publications (2)

  • Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.

    PMID: 21364460BACKGROUND

  • Sauer M, Stahn A, Soltesz S, Noeldge-Schomburg G, Mencke T. The influence of residual neuromuscular block on the incidence of critical respiratory events. A randomised, prospective, placebo-controlled trial. Eur J Anaesthesiol. 2011 Dec;28(12):842-8. doi: 10.1097/EJA.0b013e328345cd11.

    PMID: 21455074BACKGROUND

MeSH Terms

Interventions

Magnesium SulfateSodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Paulo A Germano Filho, MD

    Hospital Federal de Bonsucesso

    PRINCIPAL INVESTIGATOR

  • Núbia V Figueiredo, PhD

    Universidade Federal do Rio de Janeiro

    STUDY DIRECTOR

  • Ismar L Cavalcanti, PhD

    Universidade Federal do Rio de Janeiro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 10, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

BR(1)