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MgSO4 Combined With Rocuronium Priming

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ClinicalTrials.gov Identifier: NCT01389791
Recruitment Status : Unknown
Verified January 2012 by Kim Mihyun, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : July 8, 2011
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):

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
Muscle Relaxation Drug: magnesium sulfate Drug: priming Drug: magnesium sulfate and priming

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  (Clinical Trial)
Estimated 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 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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 Name: MgSO4


Outcome Measures

Primary Outcome Measures :
  1. time from injection of induction dose of rocuronium until 95% depression of TOF [ Time Frame: time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min ]

Secondary Outcome Measures :
  1. rocuronium duration [ Time Frame: 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 Frame: time from injection of induction dose of rocuronium until tracheal intubation. ]
    rapid sesequence intubation condition is evaluated.


Eligibility Criteria

Information from the National Library of Medicine

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

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

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): NCT01389791


Contacts
Contact: Mihyun Kim, MD 82-31-787-2034 snmd56@yahoo.com

Locations
Korea, Republic of
Seoul national university Bundang hospital Recruiting
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
More Information

Responsible Party: Kim Mihyun, full instructor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01389791     History of Changes
Other Study ID Numbers: Mg priming
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by Kim Mihyun, Seoul National University Bundang Hospital:
muscle relaxation
magnesium sulfate
rocuronium

Additional relevant MeSH terms:
Rocuronium
Magnesium Sulfate
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents