Last updated: May 8, 2024
Sponsor: Christoph Czarnetzki
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
Magnesium Sulfate
Clinical Study ID
NCT05261516
2019-02104/CE3541
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients, age 18 to 65 years inclusive
- American Society of Anesthesiology [ASA] status I or II
- Body mass index 19 - 30 kg/m2
- Patient scheduled for elective surgery lasting ≥ 60 minutes
- Patient is able to read and understand the information sheet and to sign and date theconsent form.
- Negative urinary or serum pregnancy test (not applicable if status post hysterectomyor tubal ligation or menopausal woman)
Exclusion
Exclusion Criteria:
- Surgery with need for neuromuscular block
- Contraindication for general anesthesia with laryngeal mask airway, such asgastro-oesophageal reflux.
- Hypersensitivity or allergy to magnesium sulfate or propofol
- Contraindication to volatile anesthetics such as malignant hyperthermia
- Patients with neuromuscular disease
- Patients receiving medications known to influence neuromuscular function (forinstance, aminoglycosides or phenytoine)
- Known electrolyte abnormalities (for instance, hypermagnesemia)
- Atrioventricular heart block
- Patients with magnesium treatment within 48 hours before start of study
- Liver insufficiency (bilirubine <1.5x, ALAT/ASAT<2.5x the upper limit of normal value)
- Renal insuffisancy (créatinine <1.5x upper limit of normal value,clearance<30ml/minute)
- Patient having participated in any clinical trial within 30 days, inclusive, ofsigning the informed consent form of the current trial.
- Pregnant or breast-feeding women.
Study Design
Total Participants: 96
Treatment Group(s): 1
Primary Treatment: Magnesium Sulfate
Phase: 4
Study Start date:
November 18, 2022
Estimated Completion Date:
August 31, 2025
Study Description
Connect with a study center
Division of Anesthesiology, Geneva University Hospitals
Genève, Geneva 1205
SwitzerlandSite Not Available
Division of Anesthesiology, Regional Hospital of Lugano
Lugano, 6900
SwitzerlandSite Not Available
Department of Anesthesiology and Intensive Care, Valais Hospital
Sion, 1951
SwitzerlandActive - Recruiting
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