Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

December 22, 2020 updated by: JiWon Han, Seoul National University Bundang Hospital

Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Through this study, the investigators will quantitatively analyze the rocuronium saving effect of magnesium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts on motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium saving effect of magnesium is not clear. This study's hypothesis is that magnesium would reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on recovery time, postoperative pain, nausea and vomiting.

Study Type

Interventional

Enrollment (Actual)

68

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
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • 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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients who undergo elective robot assisted radical prostatectomy, between 20 and 80 years with a American Society of Anesthesiologists physical status classification of I or II

Exclusion Criteria:

  • Conduction abnormalities in preoperative EKG such as Atrioventricular block, sinus pause
  • Glomerular filtration rate <60ml/min/1.73m2
  • Allergy to rocuronium, sugammadex, magnesium
  • Medications that interfered with muscle activity
  • Neuromuscular disease
  • Hypermagnesemia

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Magnesium Sulfate group
magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
Drug: Magnesium Sulfate
magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
PLACEBO_COMPARATOR: Placebo group
Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
Drug: Placebo
Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rocuronium amount
Time Frame: perioperative - until 48hours
total rocuronium/weight/infusion time
perioperative - until 48hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recovery time
Time Frame: perioperative - until 48hours
time from sugammadex injection to Train-of-four ratio 0.9
perioperative - until 48hours
postoperative pain
Time Frame: at postoperative 30minutes, 6hours, 24hours
11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication
at postoperative 30minutes, 6hours, 24hours
postoperative nausea and vomiting
Time Frame: at postoperative 30minutes, 6hours, 24hours
Numerical Rating Scale(0-10), rescue medication
at postoperative 30minutes, 6hours, 24hours

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Ah-young Oh, professor, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

April 26, 2019

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 6, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1902/523-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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