NCT01389791

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

May 26, 2011

Last Update Submit

January 6, 2012

Conditions

Keywords

muscle relaxationmagnesium sulfaterocuronium

Outcome Measures

Primary Outcomes (1)

  • time from injection of induction dose of rocuronium until 95% depression of TOF

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

Secondary Outcomes (2)

  • rocuronium duration

    time from injection of induction dose of rocuronium until train-of-four count reaches two.

  • intubating condition

    time from injection of induction dose of rocuronium until tracheal intubation.

Study Arms (4)

Roc

NO INTERVENTION

Patients in this group receive neither MgSO4 nor priming dose of rocuronium.

priming

ACTIVE COMPARATOR

patients in this group receive 0.06mg/kg of rocuronium before 0.54mg/kg of rocuronium.

Drug: priming

Mg&priming

EXPERIMENTAL

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

MgSO4

ACTIVE COMPARATOR

Patients in this group receive intravenous MgSO4 before administration of rocuronium.

Drug: magnesium sulfate

Interventions

Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).

Also known as: MgSO4
MgSO4

Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.

Also known as: rocuronium-priming
priming

Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.

Also known as: MgSO4 & priming
Mg&priming

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of ASA Ⅰ-Ⅱ
  • aged 18\~65
  • scheduled to undergo elective surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university Bundang hospital

Seongnam, Kyoung-ki-do, 463-707, South Korea

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Sanghwan Do, M.D., PH.D.

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Mihyun Kim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full instructor

Study Record Dates

First Submitted

May 26, 2011

First Posted

July 8, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations