NCT00405977

Brief Summary

The aim of this study is to investigate whether an optimized pre-treatment with intravenous magnesium enhances the speed of onset of a standard intubation dose of rocuronium.

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 May 2006

Typical duration 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

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

2.3 years

First QC Date

November 29, 2006

Last Update Submit

September 15, 2011

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockMagnesiumRocuroniumTime course of action

Outcome Measures

Primary Outcomes (1)

  • To study whether a pre-treatment with MgSO4, 60 mg kg-1, administered as an intravenous infusion 15 minutes prior to induction enhances the speed of onset of a standard intubation dose of rocuronium

    Onset time ist the time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the Train of four (TOF)

    1 to 5 minutes

Secondary Outcomes (2)

  • To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium

    minutes to hours

  • To study possible haemodynamic effects of pre-treatment with MgSO4.

    hours

Study Arms (2)

Physiologic saline

PLACEBO COMPARATOR
Drug: Physiologic saline

Magnesium sulphate

ACTIVE COMPARATOR
Drug: Magnesium sulphate

Interventions

Physiologic salineDRUG

Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group and 1 ml per kg physiological saline. The infusion will be given with during 15 minutes.

Physiologic saline
Magnesium sulphateDRUG

Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given during 15 minutes.

Magnesium sulphate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anaesthesiology (ASA) status I or II
  • Adults, aged 18 years to 60 years
  • Scheduled for elective surgery lasting longer than 120 min without need for continuous curarisation

You may not qualify if:

  • A history of allergy or hypersensitivity to rocuronium
  • Neuromuscular disease
  • Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics and anticonvulsants)
  • Electrolyte abnormalities
  • Hepatic or renal insufficiency
  • Patients with a body mass index \<19 or \>28 kg m2
  • Pregnant or breastfeeding women
  • Expected difficult intubation or mask ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva, Anesthesia Department

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised study. Acta Anaesthesiol Scand. 2010 Mar;54(3):299-306. doi: 10.1111/j.1399-6576.2009.02160.x. Epub 2009 Nov 16.

    PMID: 19919585RESULT

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Christoph A Czarnetzki, MD, MBA

    University Hospital of Geneva, Anesthesia Department

    PRINCIPAL INVESTIGATOR

  • Martin Tramer, MD, PhD

    University Hospital of Geneva, Anesthesia Department

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 29, 2006

First Posted

December 4, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

CH(1)