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Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatic Neoplasms

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium group

Control group

Arm Description

Intravenous administration of Magnesium Sulfate

Intravenous administration of normal saline

Outcomes

Primary Outcome Measures

Mean blood pressure

Secondary Outcome Measures

Postoperative pain
pain assessment using visual analog scale

Full Information

First Posted
July 12, 2016
Last Updated
April 3, 2019
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02833038
Brief Title
Effect of Intravenous Magnesium During Robot Assisted Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium group
Arm Type
Experimental
Arm Description
Intravenous administration of Magnesium Sulfate
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Intravenous administration of normal saline
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
the same bolus and infusion volumes of normal saline
Primary Outcome Measure Information:
Title
Mean blood pressure
Time Frame
Up to 2 hours after Trendelenburg position
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
pain assessment using visual analog scale
Time Frame
Up to 24 hours after surgery end

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Seoum
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33611742
Citation
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.
Results Reference
derived

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Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

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