Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013243
• Other study ID #: B-1902/523-007
• Status: Completed
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: December 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
• Neuromuscular Blockade

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Queiroz Rangel Micuci AJ, Verçosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rocuronium amount	total rocuronium/weight/infusion time	perioperative - until 48hours
Secondary	recovery time	time from sugammadex injection to Train-of-four ratio 0.9	perioperative - until 48hours
Secondary	postoperative pain	11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication	at postoperative 30minutes, 6hours, 24hours
Secondary	postoperative nausea and vomiting	Numerical Rating Scale(0-10), rescue medication	at postoperative 30minutes, 6hours, 24hours