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The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block (MagRoc)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405977
First Posted: December 4, 2006
Last Update Posted: September 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva
  Purpose
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.

Condition Intervention Phase
Neuromuscular Blockade Drug: Physiologic saline Drug: Magnesium sulphate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study

Resource links provided by NLM:


Further study details as provided by Christoph Czarnetzki, University Hospital, Geneva:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 to 5 minutes ]
    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)


Secondary Outcome Measures:
  • To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium [ Time Frame: minutes to hours ]
  • To study possible haemodynamic effects of pre-treatment with MgSO4. [ Time Frame: hours ]

Enrollment: 80
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Physiologic saline Drug: Physiologic saline
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.
Active Comparator: Magnesium sulphate Drug: Magnesium sulphate
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.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405977


Locations
Switzerland
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Christoph A Czarnetzki, MD, MBA University Hospital of Geneva, Anesthesia Department
Study Chair: Martin Tramer, MD, PhD University Hospital of Geneva, Anesthesia Department
  More Information

Publications:
Responsible Party: Christoph Czarnetzki, Study Leader, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00405977     History of Changes
Other Study ID Numbers: CER 05-055
First Submitted: November 29, 2006
First Posted: December 4, 2006
Last Update Posted: September 19, 2011
Last Verified: September 2011

Keywords provided by Christoph Czarnetzki, University Hospital, Geneva:
Neuromuscular block
Magnesium
Rocuronium
Time course of action

Additional relevant MeSH terms:
Rocuronium
Magnesium Sulfate
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents