Dose of Magnesium Sulfate Infusion in Obese
Best Dose of Magnesium Sulfate Infusion in Obese. A Blind and Randomized Trial
1 other identifier
interventional
75
1 country
2
Brief Summary
Magnesium sulfate has been shown to be a successful tool in a large number of clinical areas. Its benefits include neuroprotection, control of eclampsia / pre-eclampsia, control of intraoperative blood pressure, decreased neuroendocrine response during laryngoscopy and tracheal intubation and reduced levels of postoperative pain and consumption of analgesic. Obese patients have become more and more frequent in the operating rooms, due to the increasing prevalence of this population worldwide. However, although they have received magnesium sulfate as part of the analgesic strategy in many centers, there has been no study demonstrating the appropriate dose of this medication in obese patients. This study aims to compare two doses of magnesium sulfate in obese patients: based on their real weight or based on ideal weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2022
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 31, 2023
October 1, 2023
3.2 years
November 16, 2020
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesia
consumption of opioids and pain scores after surgery, during hospitalization.
Postoperative time while in hospital, up to 12 hours
Secondary Outcomes (2)
Magnesium blood concentration
At the time of venipuncture and 15, 30, 60, 120 and 240 minutes after the beginning of the covered solution.
Neuromuscular block recovery index
Intraoperative time
Study Arms (3)
Lactate ringer group
PLACEBO COMPARATORPatients will receive only general anesthesia
Real weight group
ACTIVE COMPARATORPatients who will receive general anesthesia and magnesium sulfate infused at a dose of 15 mg.kg-1.h-1 based on the actual body weight
Corrected ideal weight group
ACTIVE COMPARATORPatients who will receive general anesthesia and magnesium sulfate infused at a dose of 15 mg.kg-1.h-1 based on the corrected ideal weight
Interventions
General anesthesia only
General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's real weight
General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's corrected ideal weight
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sebastião Ernesto Silva Filho
São José dos Campos, São Paulo, 12244660, Brazil
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903, Brazil
Related Publications (6)
Crowther CA, Hiller JE, Doyle LW, Haslam RR; Australasian Collaborative Trial of Magnesium Sulphate (ACTOMg SO4) Collaborative Group. Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2669-76. doi: 10.1001/jama.290.20.2669.
PMID: 14645308BACKGROUNDDuley L, Meher S, Jones L. Drugs for treatment of very high blood pressure during pregnancy. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD001449. doi: 10.1002/14651858.CD001449.pub3.
PMID: 23900968BACKGROUNDLu JF, Nightingale CH. Magnesium sulfate in eclampsia and pre-eclampsia: pharmacokinetic principles. Clin Pharmacokinet. 2000 Apr;38(4):305-14. doi: 10.2165/00003088-200038040-00002.
PMID: 10803454BACKGROUNDJee D, Lee D, Yun S, Lee C. Magnesium sulphate attenuates arterial pressure increase during laparoscopic cholecystectomy. Br J Anaesth. 2009 Oct;103(4):484-9. doi: 10.1093/bja/aep196. Epub 2009 Jul 17.
PMID: 19617379BACKGROUNDJames MF, Beer RE, Esser JD. Intravenous magnesium sulfate inhibits catecholamine release associated with tracheal intubation. Anesth Analg. 1989 Jun;68(6):772-6.
PMID: 2735543BACKGROUNDS E SF, G F M, S D, M A M C G, F A, C B, F B S, J E V. Optimal Dose of Magnesium Sulfate Infusion in Obese Patients: A Double-Blind Randomized Trial. Anesthesiol Res Pract. 2025 Mar 19;2025:8854830. doi: 10.1155/anrp/8854830. eCollection 2025.
PMID: 40144953DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sebastião silva filho
Hospital da Sociedade de Beneficência Portuguesa d
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- A professional will arrange the electronic draw, allocate the groups and prepare the opaque envelopes. Another professional will prepare the covert solution, the prescription of which will be inside the opaque envelope. The third professional will administer the anesthesia. Another team member will collect the data and organize it in a spreadsheet. The data will be analyzed by an independent statistician. Participants and performers for each stage will be covered for each participant's group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 27, 2020
Study Start
April 1, 2022
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share