NCT04013243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

June 28, 2019

Last Update Submit

December 22, 2020

Conditions

Magnesium Sulfate Causing Adverse Effects in Therapeutic UseNeuromuscular Blockade

Keywords

Magnesium

Outcome Measures

Primary Outcomes (1)

  • rocuronium amount

    total rocuronium/weight/infusion time

    perioperative - until 48hours

Secondary Outcomes (3)

  • recovery time

    perioperative - until 48hours

  • postoperative pain

    at postoperative 30minutes, 6hours, 24hours

  • postoperative nausea and vomiting

    at postoperative 30minutes, 6hours, 24hours

Study Arms (2)

Magnesium Sulfate group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Magnesium SulfateDRUG

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

Magnesium Sulfate group
PlaceboDRUG

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

Placebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (2)

  • 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.

    PMID: 30985540RESULT

  • 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.

    PMID: 32890015DERIVED

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Ah-young Oh, professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 9, 2019

Study Start

April 26, 2019

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

December 24, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)