Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

Not Applicable

Completed

• Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use; Neuromuscular Blockade
• Interventions: Drug: Placebo; Drug: Magnesium Sulfate

• Registration Number: NCT04013243
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-04-26
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-06
• Study First Posted: 2019-07-09
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
rocuronium amount	perioperative - until 48hours	total rocuronium/weight/infusion time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of