The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00405977

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: Placebo Drug: Magnesium sulphate	Phase IV

Drug Information available for: Magnesium Magnesium sulfate Sodium chloride Rocuronium ORG 9426

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study

Further study details as provided by 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: Minutes ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
To study possible haemodynamic effects of pre-treatment with MgSO4. [ Time Frame: hours ] [ Designated as safety issue: Yes ]

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
1: Placebo Comparator	Drug: Placebo 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.
2: Active Comparator	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.

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Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405977

Locations

Switzerland, Canton of Geneva
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

Responsible Party:	Organization: Division of Anesthesiology, University Hospitals of Geneva ( Christoph Czarnetzki )
Study ID Numbers:	CER 05-055
Study First Received:	November 29, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00405977
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Neuromuscular block
Magnesium
Rocuronium
Time course of action

Study placed in the following topic categories:

Calcium, Dietary
Rocuronium
Magnesium Sulfate

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Calcium Channel Blockers
Neuromuscular Agents
Neuromuscular Blocking Agents
Reproductive Control Agents
Cardiovascular Agents

Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009