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Interaction Between Magnesium and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block (MagNeoSug)

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ClinicalTrials.gov Identifier: NCT03497923
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Hôpital du Valais
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva

Brief Summary:

Magnesium sulphate is regularly used in perioperative medicine. During and after general anesthesia, it enhances the effect of muscle relaxants because it reduces the liberation of acetylcholine at the neuromuscular junction. When administered immediately after spontaneous recovery of a neuromuscular block (NMB), magnesium may cause a recurrence of NMB and compromise patient safety.

Rocuronium is a neuromuscular blocking agent which is frequently used to facilitate intubating and surgical conditions. At the end of the procedure, there are two ways to accelerate the reversal of a neuromuscular block induced by rocuronium: 1. Administration of neostigmine, an anticholinesterase agent and competitive antagonist; 2. Administration of sugammadex, a γ-cyclodextrin compound and specific encapsulator of rocuronium.

The study is done in patients receiving rocuronium and either neostigmine or sugammadex for reversal of NMB. It is hypothesized that when sugammadex is used as an antagonist of a rocuronium-induced NMB, it prevents the reappearance of NMB when magnesium is injected, because sugammadex should inactivate all remaining rocuronium molecules and restore neuromuscular reserve of the neuromuscular junctions. Further more it is hypothesized that reversal with neostigmine will not prevent a magnesium-induced recurrence of NMB to the same extent. The primary objective of the study is to show that after reversal with sugammadex there is no or only very little re-occurrence of neuromuscular block after a magnesium perfusion. Furthermore we want to show that after reversal with neostigmine there is a re-occurrence of neuromuscular block.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arms, randomized, double blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: quadruple
Primary Purpose: Treatment
Official Title: Interaction Between Intravenous Magnesium Sulphate and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block - A Randomized, Double Blinded, Electrophysiological Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Active Comparator: Neostigmine
Patients are anesthesized with Propofol and receive 0.6mg-1 of rocuronium for tracheal intubation. Neuromuscular monitoring will be done on the ulnar nerve by train-of-four (TOF) using a TOF-Watch-SX® acceleromyograph (Organon [Ireland] Ltd). After spontaneous recovery of 2 twitches at the train-of-four monitor (TOF), patients receive neostigmine 50 μg kg-1.
Drug: Magnesium Sulfate
After reversal the obention of a TOF ratio of 0.9 is avaited. 10 minutes later patients will receive a perfusion of magnesium 60 mg kg-1 over 5 minutes.

Experimental: Sugammadex
Patients are anesthesized with Propofol and receive 0.6mg-1 of rocuronium for tracheal intubation. Neuromuscular monitoring will be done on the ulnar nerve by train-of-four (TOF) using a TOF-Watch-SX® acceleromyograph (Organon [Ireland] Ltd). After spontaneous recovery of 2 twitches at the train-of-four monitor (TOF), patients receive sugammadex (Bridion®) 2 mg kg-1.
Drug: Magnesium Sulfate
After reversal the obention of a TOF ratio of 0.9 is avaited. 10 minutes later patients will receive a perfusion of magnesium 60 mg kg-1 over 5 minutes.




Primary Outcome Measures :
  1. Proportion of patients with a decrease in TOF ratio after magnesium administration [ Time Frame: Patients will be followed over 24 hours ]
    Two consecutive measures with a value inferior to TOF 0.9


Secondary Outcome Measures :
  1. Lowest TOF ratio measured after starting the magnesium perfusion [ Time Frame: 120 minutes ]
    TOF monitoring every 15 seconds

  2. Time required for the TOF ratio to reach a TOF 0.9 [ Time Frame: 120 minutes ]
    Time in minutes



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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:

  • Patients, age ≥18 to 65 years
  • American Society of Anesthesiology [ASA] status I or II.
  • Patient is able to read and understand the information sheet and to sign and date the consent form.
  • Patient scheduled of elective surgery lasting ≥100 minutes.
  • Women on the pill should be advised to follow the missed dose advice in the product information.
  • Women using non-oral hormonal contraceptives, such as depot formulations, should be advised to use additional contraception for the next seven days.

Exclusion criteria:

  • A history of allergy or hypersensitivity to rocuronium, glycopyrronium bromide, neostigmine methylsulfate, sugammadex, or magnesium sulphate
  • Neuromuscular disease receiving medications known to influence neuromuscular function (for instance, aminoglycosides or phenytoine)
  • Preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine)
  • Patients under toremifene, flucloxacillin and fusidic acid treatment (interaction with sugammadex cannot not be excluded)
  • Electrolyte abnormalities (for instance, hypermagnesemia)
  • Atrioventricular heart block
  • Patients with magnesium treatment within 3 days before study inclusion
  • Patients with a body mass index <19 or >30 kg/m2
  • Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
  • Patients undergoing interventions that need a continuous deep NMB (for surgical reasons).
  • Pregnant or breast feeding women

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): NCT03497923


Contacts
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Contact: Christoph Czarnetzki, MD, MBA +41223723311 christoph.czarnetzki@hcuge.ch
Contact: Martin Tramèr, PhD +41223723311 martin.tramer@hcuge.ch

Locations
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Switzerland
University Hospital of Geneva, Anesthesia Department Recruiting
Geneva, Canton Of Geneva, Switzerland, 1211
Contact: Christoph A Czarnetzki, MD, MBA    0041223723311    christoph.czarnetzki@hcuge.ch   
Principal Investigator: Christoph A Czarnetzki, MD, MBA         
Hôpital du Valais Recruiting
Sion, Switzerland, 1951
Contact: Sina Grape, MD, MBA    +4127603 ext 8759    sina.grape@hopitalvs.ch   
Sponsors and Collaborators
Christoph Czarnetzki
Hôpital du Valais
Investigators
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Study Chair: Christoph Czarnetzki, MD, MBA University Hospital Geneve
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Responsible Party: Christoph Czarnetzki, Doctor, MBA, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03497923    
Other Study ID Numbers: CCER 2016-00018
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christoph Czarnetzki, University Hospital, Geneva:
rocuronium, magnesium sulphate, neostigmine, sugammadex
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