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NCT Number: NCT04013243

Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

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.

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Key information

Conditions

Magnesium Sulfate Causing Adverse Effects in Therapeutic Use Neuromuscular Blockade

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion

Placebo

Drug

Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.

Primary outcomes

  1. rocuronium amount

    Time frame: perioperative - until 48hours

    total rocuronium/weight/infusion time

Secondary outcomes

  1. recovery time

    Time frame: perioperative - until 48hours

    time from sugammadex injection to Train-of-four ratio 0.9

  2. postoperative pain

    Time frame: at postoperative 30minutes, 6hours, 24hours

    11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication

  3. postoperative nausea and vomiting

    Time frame: at postoperative 30minutes, 6hours, 24hours

    Numerical Rating Scale(0-10), rescue medication

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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