Effect of Intravenous Magnesium During Robot Assisted Prostatectomy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedApril 5, 2019
April 1, 2019
3 years
July 12, 2016
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean blood pressure
Up to 2 hours after Trendelenburg position
Secondary Outcomes (1)
Postoperative pain
Up to 24 hours after surgery end
Study Arms (2)
Magnesium group
EXPERIMENTALIntravenous administration of Magnesium Sulfate
Control group
PLACEBO COMPARATORIntravenous administration of normal saline
Interventions
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
Eligibility Criteria
You may qualify if:
- Robot assisted prostatectomy
You may not qualify if:
- Allergy to magnesium
- Chronic pain
- Chronic opioid use
- Chronic NSAID use
- Renal dysfunction
- Liver dysfunction
- Cardiac arrythmia
- Seizure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum, South Korea
Related Publications (1)
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.
PMID: 33611742DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 14, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
April 5, 2019
Record last verified: 2019-04