Effect of Magnesium Sulphate on Neostigmine

Neuromuscular Blockade Clinical Trial

Official title:

Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03020706
• Other study ID #: B-1610/367-002
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2017
• Last updated: January 11, 2017
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Gachon University Gil Medical Center
• Contact: Hee-Yeon Park, MD
• Phone: +82 10 3360 0790
• Email: hypark[@]gilhospital.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

Comparison of reversa time by neostigmine in magnesium group and control group

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Magnesium Sulfate, Injectable
magnesium sulphate intravenous administration during general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyungi-do

Sponsors (2)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reversal time	reversal time: from neostigmine injection to TOF ratio 0.9	through study completion, an average of 90 minutes	No