Clinical trial NCT04013243: Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade
Official title: Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
Neuromuscular Blockade
Keywords: Magnesium
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 68
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: rocuronium amount
timeFrame: perioperative - until 48hours
Secondary outcomes:
measure: recovery time
timeFrame: perioperative - until 48hours
measure: postoperative pain
timeFrame: at postoperative 30minutes, 6hours, 24hours
measure: postoperative nausea and vomiting
timeFrame: at postoperative 30minutes, 6hours, 24hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ah-young Oh, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Queiroz Rangel Micuci AJ, Vercosa 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 Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
citation: Han J, Jeon YT, Ryu JH, Koo CH, Nam SW, Cho SI, Oh AY. Effects of magnesium on the dose of rocuronium for deep neuromuscular blockade: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):432-437. doi: 10.1097/EJA.0000000000001329.