Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
74 participants
INTERVENTIONAL
2019-08-26
2020-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
NCT04005599
Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
NCT05227716
Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
NCT04938765
Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries
NCT02508857
Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium
NCT02989272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Main objective: To determine the optimum strategy to safely and effectively obtain the value of magnesium concentration in the blood of obese population.
Secondary objectives: To evaluate postoperative analgesia and the pharmacokinetic profile of neuromuscular blocker used in each group.
Hypothesis: The null hypothesis is that no matter which method we use to calculate the magnesium sulfate dosage, the blood magnesium concentration will be the same. The alternative hypothesis is that magnesium sulfate dosage based on the patient's actual weight generates higher concentrations of magnesium than that required for postoperative analgesia, as compared with dosage based on that corrected ideal weight of the patient.
Trial design: this is a prospective, controlled, randomized and double-blind clinical trial.
Study setting This study will be conducted at Beneficence Portuguese Society, Santos, an academic hospital, in São Paulo, Brazil. A sample of 75 participants will be recruited from a population of obese patients scheduled to undergo cholecystectomy or bariatric surgery through laparoscopy.
Interventions In the first phase of the trial, 10 patients with body mass index 20-30 kg/m² will be administered magnesium sulphate 40 mg/kg at anesthetic induction. In all patients, blood collection will be conducted before administration of magnesium sulfate, and at 15, 30, 60, 120 and 240 minutes after administration of magnesium sulfate.
In the second phase of the trial, from among obese patients scheduled to undergo cholecystectomy or bariatric surgery through laparoscopy at our institute, 75 patients will be invited to participate in the trial. Participants will be assigned to three groups by electronic randomization process as follow: Placebo group (PG) without administration of magnesium sulfate; real weight group (RWG) administration of magnesium sulfate at 40 mg/kg of the patient's actual weight; corrected ideal weight group (CWG) administration of magnesium sulphate at 40 mg/kg of patient's corrected ideal weight.
The corrected ideal weight will be calculated using the following formulas:
Ideal weight Man = height (cm) - 100 Woman = height (cm) - 105 Corrected ideal weight = Ideal weight + (0,4 x difference between the real and ideal weight) The participants will not be administered any sedative agent before anesthetic induction. At arrival in the operating room, all patients will undergo electrocardiography, noninvasive blood pressure measurement, pulse oximetry, monitoring of neuromuscular function, and that of the level of consciousness. Venous access and hydration will be achieved according to the anesthesiologist's judgment. At the time of puncture of the vein, the first 2-ml blood sample will be collected to establish the basal concentration of magnesium in the blood. Within 10 min after collection of the blood, dosage will be calculated according to the following chart (Figure 1).
In all participants, infusion of treatment solution will be performed by a blinded investigator, and ketoprofen 100 mg, clonidine 2 µg/kg, cefazolin 2 g, dexamethasone 4 mg, ranitidine 50 mg and lidocaine 1,5 mg/kg will be administered simultaneously. At the end of infusion participants will undergo pre-oxygenation with 100% O2 for 3 to 5 min, followed by propofol through target controlled infusion with initial target of 4 µg/ml according to Marsh's pharmacokinetic model, under monitoring for the level of hypnoses. At the time of adequate level of hypnoses, revealed by the hypnoses monitor (SedLine® Brain Function Monitoring) calibration of the monitor of neuromuscular function (train-of-four - TOF) will be performed; subsequently, cisatracurium 0.15 mg/kg will be administered, and target-controlled infusion of remifentanil (Minto's pharmacokinetic model) at initial target concentration of 5 ng/ml will be conducted. Under hypnoses monitoring, 0.03 mg/kg cisatracurium will be administered if TOF ≥ 2 is observed or on surgical demand. Remifentanil infusion will be conducted according to the patient's hemodynamics, such that systolic pressure is maintained within 30% limits from the baseline value, or maximum value of 130 mmHg and minimum value of 90 mmHg are achieved. During the last 20 minutes' period of surgery, cisatracurium will be withheld, when possible. At the end of surgery, at TOF \> 2, atropine 20 µg/kg and neostigmine 40 µg/kg will be administered.
Before extubation, the patients in both groups will be administered morphine 0,05 mg/kg and dipyrone 30 mg/kg. Five minutes after extubation and after each 30 minutes' interval, repeat dose of morphine will be administered at pain-score of \> 3 (0 to 10) of the patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo group
Patient will be administered saline solution followed by venous general anesthesia.
Placebo group
Saline solution (instead of magnesium sulfate, as in the other groups)
Magnesium sulfate through real weight group
Patient will be administered magnesium sulfate 40 mg/kg of the patient's actual weight followed by venous general anesthesia.
Magnesium sulfate through real weight group
Magnesium sulfate dose 40 mg/kg of actual patient's weight
Magnesium sulfate through ideal corrected weight group
Patient will be administered magnesium sulfate 40 mg/kg of the patient's ideal corrected weight followed by venous general anesthesia.
Magnesium sulfate through ideal corrected weight group
Magnesium sulfate dose 40 mg/kg of ideal corrected patient's weight
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium sulfate through real weight group
Magnesium sulfate dose 40 mg/kg of actual patient's weight
Placebo group
Saline solution (instead of magnesium sulfate, as in the other groups)
Magnesium sulfate through ideal corrected weight group
Magnesium sulfate dose 40 mg/kg of ideal corrected patient's weight
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* body mass index \> 30 kg/m²
* American Society of Anesthesiologists score \< III.
Exclusion Criteria
* refusal to participate or sign the consent form
* any global diagnosed neuromuscular disorder
* cardiac conduction blockade higher than atrioventricular block II
* use of illicit drugs, use of calcium channel blockers
* creatinine \> 2 mg/dl.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joaquim Edson Vieira
Associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joaquim Vieira, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo School of Medicine
Sebastião Silva Filho, Physician
Role: STUDY_CHAIR
University of Sao Paulo School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE 09006119.2.0000.5501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.