MgSO4 Combined With Rocuronium Priming

Study Description

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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
Muscle Relaxation	Drug: magnesium sulfate; Drug: priming; Drug: magnesium sulfate and priming	Not Applicable

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

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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

Arms and Interventions

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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