Magnesium Sulfate Dose in Obese Patients.

NCT04003688 | Completed

• 1 other identifier: CAAE 09006119.2.0000.5501
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium sulfate has been applied in various situations due to actual or potential benefits related to neuroprotection, treatment of eclampsia/pre-eclampsia, arterial hypertension, adrenergic reflex under laryngoscopy/intubation and, shivering, nausea and vomiting, among others. In anesthesia it has been useful as an analgesic adjuvant; however, the method to calculate the dose of magnesium sulfate in obese population is unclear. The objective of this project is to compare two methods of dose calculation based either on the real weight or corrected ideal weight.

Conditions

Magnesium Sulfate; Postoperative Pain; Obesity

Outcome Measures

Primary Outcomes (1)

• Magnesium blood concentration at the preset timepoints.

  Comparison of the magnesium concentration (mg/ml) in blood between groups

  Four hours

Secondary Outcomes (2)

• Opioid consumption

  Four hours.

• Time to recovery from neuromuscular blockade

  During recovery time (just after the end of surgery)

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Patient will be administered saline solution followed by venous general anesthesia.

Drug: Placebo group

Magnesium sulfate through real weight group

EXPERIMENTAL

Patient will be administered magnesium sulfate 40 mg/kg of the patient's actual weight followed by venous general anesthesia.

Drug: Magnesium sulfate through real weight group

Magnesium sulfate through ideal corrected weight group

EXPERIMENTAL

Patient will be administered magnesium sulfate 40 mg/kg of the patient's ideal corrected weight followed by venous general anesthesia.

Drug: Magnesium sulfate through ideal corrected weight group

Interventions

Magnesium sulfate through real weight group DRUG

Magnesium sulfate dose 40 mg/kg of actual patient's weight

Also known as: Real weight group

Magnesium sulfate through real weight group

Placebo group DRUG

Saline solution (instead of magnesium sulfate, as in the other groups)

Placebo group

Magnesium sulfate through ideal corrected weight group DRUG

Magnesium sulfate dose 40 mg/kg of ideal corrected patient's weight

Also known as: Ideal weight group

Magnesium sulfate through ideal corrected weight group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 60 year-old
• body mass index \> 30 kg/m²
• American Society of Anesthesiologists score \< III.

You may not qualify if:

• Allergy to any medications of the trial
• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Joaquim Vieira, Professor

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

• Sebastião Silva Filho, Physician

  University of Sao Paulo School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist in charge of randomization will number 75 opaque envelopes and insert a card in each with the corresponding information of the group (according to the lottery) and the medication to be administered. Another anesthesiologist in charge of preparing the blind solution alone will open the envelope. Both of these investigators, as well as the anesthesiologist providing anesthesia and the anesthesiologist in charge of data evaluation will not participate in any of the other steps of the trial. The patients will be blinded to their own treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Prospective, double-blind, randomized clinical trial.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 1, 2019
• Study Start: August 26, 2019
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)