NCT03020706

Brief Summary

The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium

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
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 8, 2017

Last Update Submit

January 11, 2017

Conditions

Neuromuscular Blockade

Keywords

magnesium sulphateneostigmine

Outcome Measures

Primary Outcomes (1)

  • reversal time

    reversal time: from neostigmine injection to TOF ratio 0.9

    through study completion, an average of 90 minutes

Study Arms (2)

Magnesium

EXPERIMENTAL

magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia

Drug: Magnesium Sulfate, Injectable

Control

NO INTERVENTION

No intervention

Interventions

Magnesium Sulfate, InjectableDRUG

magnesium sulphate intravenous administration during general anesthesia

Also known as: magnesium sulphate
Magnesium

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status 1 or 2
  • patients undergoing surgery for more than 60 min under general anesthesia

You may not qualify if:

  • electrolyte abnormalities
  • medication on aminoglycoside, antiepileptic drug, magnesium
  • underweight or obesity (BMI \<18.5 or \>30)
  • renal insufficiency (Cr\>1.4 mg/dl)
  • AV block
  • neuromuscular disease (ex: Myathenia gravis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Kyungi-do, South Korea

RECRUITING

MeSH Terms

Interventions

Magnesium SulfateInjections

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Sang-Hwan Do, MD, Ph D

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Hee-Yeon Park, MD

CONTACT

+82 10 3360 0790hypark@gilhospital.com

Sang-Hwan Do, MD, Ph D

CONTACT

shdo@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 13, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

KR(1)