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MgSO4 Combined With Rocuronium Priming

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01389791
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
8
Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming.

Condition or Disease Intervention/Treatment Phase
  • Drug: magnesium sulfate
  • Drug: priming
  • Drug: magnesium sulfate and priming
 N/A

Detailed Description

Acceleration of muscle relaxation is beneficial in rapid-sequence intubation. If MgSO4 combined with priming is efficient in accelerating muscle relaxation, it would be an interesting alternative to rapid-sequence intubation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
MgSO4 Combined With Rocuronium Priming
Study Start Date :
May 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2012
Anticipated Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Roc

Patients in this group receive neither MgSO4 nor priming dose of rocuronium.
Active Comparator: priming

patients in this group receive 0.06mg/kg of rocuronium before 0.54mg/kg of rocuronium.

Drug: priming
Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
Other Names:
  • rocuronium-priming

    		•
    Experimental: Mg&priming

    Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.

    Drug: magnesium sulfate and priming
    Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
    Other Names:
  • MgSO4 & priming

    		•
    Active Comparator: MgSO4

    Patients in this group receive intravenous MgSO4 before administration of rocuronium.

    Drug: magnesium sulfate
    Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).
    Other Names:
  • MgSO4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time from injection of induction dose of rocuronium until 95% depression of TOF [time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min]

    Secondary Outcome Measures

    1. rocuronium duration [time from injection of induction dose of rocuronium until train-of-four count reaches two.]

      time from injection of induction dose of rocuronium until train-of-four count reaches two.

    2. intubating condition [time from injection of induction dose of rocuronium until tracheal intubation.]

      rapid sesequence intubation condition is evaluated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients of ASA Ⅰ-Ⅱ

    • aged 18~65

    • scheduled to undergo elective surgery under general anesthesia

    Exclusion Criteria:

    • risk of pulmonary aspiration

    • anticipated airway difficulty

    • reactive airway disease

    • allergic to study drugs

    • neuromuscular / cardiovascular/ renal/ hepatic disease

    • atrioventricular conduction disturbance

    • BMI < 18.5 or > 24.9

    • chronic treatment with calcium channel blocker

    • medications which affect muscle relaxation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul national university Bundang hospital Seongnam Kyoung-ki-do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Study Chair: Sanghwan Do, M.D., PH.D., Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kim Mihyun, full instructor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT01389791
    Other Study ID Numbers:
    • Mg priming
    First Posted:
    Jul 8, 2011
    Last Update Posted:
    Jan 10, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Kim Mihyun, full instructor, Seoul National University Bundang Hospital
    muscle relaxation
    magnesium sulfate
    rocuronium
    Additional relevant MeSH terms:
    Magnesium Sulfate
    Rocuronium

    Study Results

    No Results Posted as of Jan 10, 2012