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出境医 / 临床实验 / Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

Study Description
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.

Condition or disease Intervention/treatment Phase
Magnesium Sulfate Causing Adverse Effects in Therapeutic Use Neuromuscular Blockade Drug: Magnesium Sulfate Drug: Placebo Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
Actual Study Start Date : April 26, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Magnesium Sulfate group
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
magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
Placebo Comparator: Placebo group
Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
 Drug: Placebo
Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
Outcome Measures
Primary Outcome Measures :
  1. rocuronium amount [ Time Frame: perioperative - until 48hours ]
    total rocuronium/weight/infusion time


Secondary Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ah-young Oh, professor Seoul National University Bundang Hospital
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE April 26, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		rocuronium amount [ Time Frame: perioperative - until 48hours ]
total rocuronium/weight/infusion time
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2019) 		rocuronium amount [ Time Frame: perioperative - until 48hr ]
total rocuronium/weight/infusion time
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • recovery time [ Time Frame: perioperative - until 48hours ]
    time from sugammadex injection to Train-of-four ratio 0.9
  • postoperative pain [ Time Frame: at postoperative 30minutes, 6hours, 24hours ]
    11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication
  • postoperative nausea and vomiting [ Time Frame: at postoperative 30minutes, 6hours, 24hours ]
    Numerical Rating Scale(0-10), rescue medication
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2019)
  • recovery time [ Time Frame: perioperative - until 48hr ]
    time from sugammadex injection to Train-of-four ratio 0.9
  • postoperative pain [ Time Frame: at postoperative 30minutes, 6hours, 24hours ]
    11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication
  • postoperative nausea and vomiting [ Time Frame: at postoperative 30minutes, 6hours, 24hours ]
    Numerical Rating Scale(0-10), rescue medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade
Official Title  ICMJE Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
  • Neuromuscular Blockade
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
Study Arms  ICMJE
  • Active Comparator: Magnesium Sulfate group
    magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Placebo group
    Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
    Intervention: Drug: Placebo
Publications *
  • 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 Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2020) 		68
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2019) 		70
Actual Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013243
Other Study ID Numbers  ICMJE B-1902/523-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party JiWon Han, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ah-young Oh, professor Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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