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Dose of Magnesium Sulfate Infusion in Obese

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ClinicalTrials.gov Identifier: NCT04645719
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Joaquim Edson Vieira, University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Obese Analgesia Other: Lactate ringer group Drug: Magnesium sulfate dose through real weight group Drug: Magnesium sulfate dose through corrected ideal weight group Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, controlled, randomized and covered clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Best Dose of Magnesium Sulfate Infusion in Obese. A Blind and Randomized Trial
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Lactate ringer group
Patients will receive only general anesthesia
Other: Lactate ringer group
General anesthesia only
Other Name: Placebo comparator

Active Comparator: Real weight group
Patients 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
Drug: Magnesium sulfate dose through real weight group
General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's real weight
Other Name: Active comparator 1

Active Comparator: Corrected ideal weight group
Patients 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
Drug: Magnesium sulfate dose through corrected ideal weight group
General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's corrected ideal weight
Other Name: Active comparator 2




Primary Outcome Measures :
  1. Postoperative analgesia [ Time Frame: Postoperative time while in hospital, up to 12 hours ]
    consumption of opioids and pain scores after surgery, during hospitalization.


Secondary Outcome Measures :
  1. Magnesium blood concentration [ Time Frame: At the time of venipuncture and 15, 30, 60, 120 and 240 minutes after the beginning of the covered solution. ]
    Blood will be collected to examine the blood concentration of magnesium in all patients in the 3 groups

  2. Neuromuscular block recovery index [ Time Frame: Intraoperative time ]
    Cisatracurium latency, cisatracurium duration 25, total duration of cisatracurium, cisatracurium recovery index



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: healthy patients, patients with controlled systemic disease (arterial hypertension, endocrine disease), obese patients.

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Exclusion Criteria: heart block, illicit drugs use, with neuropsychiatric impairment, in blockers calcium channels and with renal impairment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645719


Contacts
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Contact: sebastião silva filho 12991457764 sebasernesto@gmail.com

Locations
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Brazil
Sebastião Ernesto Silva Filho Not yet recruiting
São José Dos Campos, SP, Brazil, 12244660
Contact: sebastião s ernesto    12991457764    sebasernesto@gmail.com   
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Brazil, 01246-903
Contact: joaquim vieira, MD    55-11-30618716    joaquimve@usp.br   
Contact: Sebastião Silva Filho, Physician    12991457764    sebasernesto@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: sebastião silva filho Hospital da Sociedade de Beneficência Portuguesa d
Publications:
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Responsible Party: Joaquim Edson Vieira, Associate professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04645719    
Other Study ID Numbers: CAAE 33298720.0.0000.5448
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents