Study Results
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Basic Information
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RECRUITING
PHASE4
96 participants
INTERVENTIONAL
2022-11-18
2025-08-31
Brief Summary
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Detailed Description
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Volatiles anesthetics influence neuromuscular transmission. They inhibit postsynaptic nicotinic acetylcholine receptors by causing open channel block, receptor desensitization and reducing exocytosis from pre-synaptic vesicles at the neuromuscular junction. The ranking order of these effects of volatile anesthetics on neuromuscular transmission is: desflurane \> sevoflurane \> isoflurane, depending on their blood-gas and tissue-gas solubility index.
Magnesium given intravenously during volatile anesthesia induces effects on neuromuscular transmission similar to that of neuromuscular blocking agents. This effect has never been investigated and quantified systematically and prospectively.
Propofol, an intravenous anesthetic, has very little effects on neuromuscular transmission. Therefore magnesium given intravenously during total intravenous anesthesia with propofol has no or only very little effect on neuromuscular transmission.
The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by accelerometry with theTetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol. The investigators expect a following rank order of the effect: desflurane \> sevoflurane \> isoflurane \> propofol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
In contrast, the investigator evaluating the patient in the postanesthetic care unit and for the 24 h postoperative visit will be blinded to the study group allocation.
The patient will also be blinded to the study group allocation.
Study Groups
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Propofol
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given.
In patients in the propofol group, anesthesia will be induced and maintained with a total intravenous anesthesia pump following the model of Schnider et al, at a targeted effect-site concentration of 4 +/- 1 mcg/ml.
In patients in all groups, after induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
Magnesium Sulfate
The experimental intervention is the injection of magnesium sulfate. This will be done as soon as TetraGraph calibration is done and neuromuscular measurements are stable. Each patient will receive 60 mg/kg of magnesium sulfate as an intravenous perfusion over 5 minutes. Vital signs before, during and after the perfusion will be taken and documented.
Isoflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: isoflurane in this group.
Magnesium Sulfate
The experimental intervention is the injection of magnesium sulfate. This will be done as soon as TetraGraph calibration is done and neuromuscular measurements are stable. Each patient will receive 60 mg/kg of magnesium sulfate as an intravenous perfusion over 5 minutes. Vital signs before, during and after the perfusion will be taken and documented.
Desflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: desflurane in this group.
Magnesium Sulfate
The experimental intervention is the injection of magnesium sulfate. This will be done as soon as TetraGraph calibration is done and neuromuscular measurements are stable. Each patient will receive 60 mg/kg of magnesium sulfate as an intravenous perfusion over 5 minutes. Vital signs before, during and after the perfusion will be taken and documented.
Sevoflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: sevoflurane in this group.
Magnesium Sulfate
The experimental intervention is the injection of magnesium sulfate. This will be done as soon as TetraGraph calibration is done and neuromuscular measurements are stable. Each patient will receive 60 mg/kg of magnesium sulfate as an intravenous perfusion over 5 minutes. Vital signs before, during and after the perfusion will be taken and documented.
Interventions
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Magnesium Sulfate
The experimental intervention is the injection of magnesium sulfate. This will be done as soon as TetraGraph calibration is done and neuromuscular measurements are stable. Each patient will receive 60 mg/kg of magnesium sulfate as an intravenous perfusion over 5 minutes. Vital signs before, during and after the perfusion will be taken and documented.
Eligibility Criteria
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Inclusion Criteria
* 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 the consent form.
* Negative urinary or serum pregnancy test (not applicable if status post hysterectomy or tubal ligation or menopausal woman)
Exclusion Criteria
* Contraindication for general anesthesia with laryngeal mask airway, such as gastro-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 (for instance, 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, of signing the informed consent form of the current trial.
* Pregnant or breast-feeding women.
18 Years
65 Years
ALL
Yes
Sponsors
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Centre Hospitalier du Centre du Valais
OTHER
Ospedale Regionale di Lugano
OTHER
Christoph Czarnetzki
OTHER
Responsible Party
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Christoph Czarnetzki
Consultant
Locations
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Department of Anesthesiology and Intensive Care, Valais Hospital
Sion, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-02104/CE3541
Identifier Type: -
Identifier Source: org_study_id
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