- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03020706
Effect of Magnesium Sulphate on Neostigmine
January 11, 2017 updated by: Park Hee-Yeon, Gachon University Gil Medical Center
Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium
The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Comparison of reversa time by neostigmine in magnesium group and control group
Study Type
Interventional
Enrollment (Anticipated)
166
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 Contact
- Name: Hee-Yeon Park, MD
- Phone Number: +82 10 3360 0790
- Email: hypark@gilhospital.com
Study Contact Backup
- Name: Sang-Hwan Do, MD, Ph D
- Email: shdo@snu.ac.kr
Study Locations
-
-
Kyungi-do
-
Seongnam, Kyungi-do, Korea, Republic of
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Hee-Yeon Park, MD
- Phone Number: +82 10 3360 0790
- Email: hypark@gilhospital.com
-
-
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
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA status 1 or 2
- patients undergoing surgery for more than 60 min under general anesthesia
Exclusion Criteria:
- 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)
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Experimental: Magnesium
magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia
|
magnesium sulphate intravenous administration during general anesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reversal time
Time Frame: through study completion, an average of 90 minutes
|
reversal time: from neostigmine injection to TOF ratio 0.9
|
through study completion, an average of 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Sang-Hwan Do, MD, 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
December 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
January 8, 2017
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 13, 2017
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- B-1610/367-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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