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

15. september 2011 opdateret af: Christoph Czarnetzki, University Hospital, Geneva

The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

In a previous study pre-treatment with intravenous MgSO4 60 mg kg-1 was not shown to have any impact on the onset of action of rocuronium [Kussmann et al, 1997]. Yet, in that study, MgSO4 was injected as a bolus after induction of anaesthesia, one minute only before the injection of the neuromuscular blocking agent. We suppose that magnesium needs some time to penetrate the neuromuscular endplate and to shift the Mg/Ca ratio in favor of magnesium. Thus, the particular design of the previous study may explain why magnesium had no scope to enhance the speed of onset of action of rocuronium.

The aim of our study is to investigate whether an optimised pre-treatment with magnesium (short infusion rather than bolus injection; reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent) enhances the speed of onset of a standard intubation dose of rocuronium.

  1. Preanaesthetic preparation

    • Solid food and liquid intake will not be allowed for a minimum of six hours before induction
    • Patients will be premedicated with 7.5 mg oral midazolam 45 min prior to induction
    • Standard monitoring will consist of: ECG, SaO2, ETCO2, non-invasive blood pressure, rectal or oesophageal T°
  2. Study drug administration

    • 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 with an Infusomat during 15 minutes.
  3. Induction and maintenance of anaesthesia

    • At the end of the study drug infusion, and after a preoxygenation period of three minutes, anaesthesia will be induced with sufentanil 0.2µg kg-1 and propofol, using a Target Controlled Infusion (TCI) system (Base Primea, Fresenius-Vial, Brezins, France) and the pharmacokinetic model of Schnider et al [Schnider et al, 1999]. The initial effect site concentration will be 4 µg ml-1.
    • Maintenance of anaesthesia will be with a propofol effect site
  4. Neuromuscular monitoring

    • Neuromuscular function will be monitored using the TOF Watch® SX (NV Organon) and TOF nerve stimulation. The guidelines for good clinical research practice in pharmacodynamic studies of NMBAs will be followed.
    • The ulnar nerve is stimulated through surface electrodes, and the adductor pollicis muscle response is measured.
    • After the stabilisation period, rocuronium 0.6 mg kg-1 (2 x ED95) will be injected intravenously during 5 seconds.
    • The trachea will be intubated after a 95% depression of the first twitch

5.1. Neuromuscular measurements

  • Onset time = time from beginning of injection of rocuronium until a 95% depression of the first twitch (T1).
  • Duration 25% = time from beginning of injection of rocuronium until 25% T1 recovery.
  • Recovery index T25-75 = time between 25% T1 recovery and 75% T1 recovery.
  • Clinical recovery T25 - 0.9 = time between 25% T1 recovery and TOF ratio (T1/T4) of 0.9 (corresponding to safe extubation condition).

5.2. Haemodynamics

  • Blood pressure
  • Heart rate These measurements will be done before (baseline), and at 5-minute intervals during the study drug infusion. Before and immediately after tracheal intubation, haemodynamic measurements will be repeated.

5.3. Adverse events, safety

  • Any minor adverse event (no need for intervention) or major adverse events will be recorded.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Canton of Geneva
      • Geneva, Canton of Geneva, Schweiz, 1211
        • University Hospital of Geneva, Anesthesia Department

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Fysiologisk saltvand
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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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)
1 to 5 minutes

Sekundære resultatmål

Resultatmål
Tidsramme
To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium
Tidsramme: minutes to hours
minutes to hours
To study possible haemodynamic effects of pre-treatment with MgSO4.
Tidsramme: hours
hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Christoph A Czarnetzki, MD, MBA, University Hospital of Geneva, Anesthesia Department
  • Studiestol: Martin Tramer, MD, PhD, University Hospital of Geneva, Anesthesia Department

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

29. november 2006

Først indsendt, der opfyldte QC-kriterier

29. november 2006

Først opslået (Skøn)

4. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2011

Sidst verificeret

1. september 2011

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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