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Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex

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ClinicalTrials.gov Identifier: NCT01828385
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 21, 2015
Sponsor:
Collaborator:
Hospital Federal de Bonsucesso
Information provided by (Responsible Party):
Paulo Alipio Germano Filho, Universidade Federal do Rio de Janeiro

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Magnesium Sulfate Drug: Saline Phase 4

Detailed Description:

Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.

Primary outcome: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium.

Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group Mg
Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
Drug: Magnesium Sulfate
Magnesium sulfate + rocuronium + sugammadex

Active Comparator: Group C
Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
Drug: Saline
Saline + rocuronium + sugammadex




Primary Outcome Measures :
  1. Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate [ Time Frame: 3 hours ]
    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.


Secondary Outcome Measures :
  1. Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room [ Time Frame: 4 hours ]
    Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT01828385


Locations
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Brazil
Hospital Federal de Bonsucesso
Rio de Janeiro, RJ, Brazil, 21041-030
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Hospital Federal de Bonsucesso
Investigators
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Principal Investigator: Paulo A Germano Filho, MD Hospital Federal de Bonsucesso
Study Director: Núbia V Figueiredo, PhD Universidade Federal do Rio de Janeiro
Study Director: Ismar L Cavalcanti, PhD Universidade Federal do Rio de Janeiro
Publications:
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Responsible Party: Paulo Alipio Germano Filho, MD, MSc, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01828385    
Other Study ID Numbers: PAGF-01M
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Paulo Alipio Germano Filho, Universidade Federal do Rio de Janeiro:
Physiological Effects of Drugs
Rocuronium
Sugammadex sodium
Magnesium
Molecular Mechanisms of Pharmacological Action
Neuromuscular block, antagonism
Pharmacologic Actions
Additional relevant MeSH terms:
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Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents