MgSO4 Combined With Rocuronium Priming

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2012 by Seoul National University Bundang Hospital.
Recruitment status was Recruiting

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:

Drug Information available for: Magnesium Magnesium sulfate Sulfate ion Rocuronium bromide Rocuronium

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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