MgSO4 Combined With Rocuronium Priming

January 6, 2012 updated by: Kim Mihyun, Seoul National University Bundang Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyoung-ki-do
      • Seongnam, Kyoung-ki-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • MgSO4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
time from injection of induction dose of rocuronium until tracheal intubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Chair: Sanghwan Do, M.D., PH.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mg priming

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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