Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

April 3, 2019 updated by: Ji Eun Kim, Ajou University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoum
      • Suwon, Seoum, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium group
Intravenous administration of Magnesium Sulfate
Drug: Magnesium Sulfate
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
Placebo Comparator: Control group
Intravenous administration of normal saline
Drug: Normal saline
the same bolus and infusion volumes of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean blood pressure
Time Frame: Up to 2 hours after Trendelenburg position
Up to 2 hours after Trendelenburg position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Up to 24 hours after surgery end
pain assessment using visual analog scale
Up to 24 hours after surgery end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-16-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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