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
About this trial
This is an interventional prevention trial for Prostatic Neoplasms
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
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
NCT ID
NCT02833038
First Posted
July 12, 2016
Last Updated
April 3, 2019
Sponsor
Ajou University School of Medicine
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
Learn more about this trial
Effect of Intravenous Magnesium During Robot Assisted Prostatectomy
We'll reach out to this number within 24 hrs