Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

NCT ID: NCT02833038

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-04-30

Brief Summary

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The primary purpose of this study is to investigate the effect of intravenous magnesium on blood pressure after Trendelenburg position during robot assisted prostatectomy.

The secondary purpose of this study is to investigate the effect of intravenous magnesium on pain after robot assisted prostatectomy.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Magnesium group

Intravenous administration of Magnesium Sulfate

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h

Control group

Intravenous administration of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

the same bolus and infusion volumes of normal saline

Interventions

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Magnesium Sulfate

adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h

Intervention Type DRUG

Normal saline

the same bolus and infusion volumes of normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Robot assisted prostatectomy

Exclusion Criteria

* Allergy to magnesium
* Chronic pain
* Chronic opioid use
* Chronic NSAID use
* Renal dysfunction
* Liver dysfunction
* Cardiac arrythmia
* Seizure
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ji Eun Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Site Status

Countries

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South Korea

References

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Kim HY, Lee SY, Lee HS, Jun BK, Choi JB, Kim JE. Beneficial Effects of Intravenous Magnesium Administration During Robotic Radical Prostatectomy: A Randomized Controlled Trial. Adv Ther. 2021 Mar;38(3):1701-1712. doi: 10.1007/s12325-021-01643-8. Epub 2021 Feb 21.

Reference Type DERIVED
PMID: 33611742 (View on PubMed)

Other Identifiers

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AJIRB-MED-CT4-16-074

Identifier Type: -

Identifier Source: org_study_id

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