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MgSO4 Combined With Rocuronium Priming

This study is currently recruiting participants.
Verified January 2012 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01389791
First received: May 26, 2011
Last updated: January 6, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MgSO4 Combined With Rocuronium Priming

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rocuronium duration [ Time Frame: time from injection of induction dose of rocuronium until train-of-four count reaches two. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kim Mihyun, full instructor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01389791     History of Changes
Other Study ID Numbers: Mg priming
Study First Received: May 26, 2011
Last Updated: January 6, 2012
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Magnesium Sulfate
Rocuronium
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on May 16, 2013