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MgSO4 Combined With Rocuronium Priming

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Kim Mihyun, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389791
First Posted: July 8, 2011
Last Update Posted: January 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
  Purpose
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 Intervention
Muscle Relaxation Drug: magnesium sulfate Drug: priming Drug: magnesium sulfate and priming

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MgSO4 Combined With Rocuronium Priming

Resource links provided by NLM:


Further study details as provided by Kim Mihyun, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

  • intubating condition [ Time Frame: time from injection of induction dose of rocuronium until tracheal intubation. ]
    rapid sesequence intubation condition is evaluated.


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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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 Submitted: May 26, 2011
First Posted: July 8, 2011
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


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