Interaction of Volatile Anesthetics With Magnesium

NCT05261516 | Recruiting Phase 4

• 1 other identifier: 2019-02104/CE3541
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium and volatiles anesthetics both have an effect on the neuromuscular transmission. The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by electromyography device TetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol.

Conditions

Neuromuscular Blockade

Keywords

Magnesium; Volatiles anesthetics; Neuromuscular transmission

Outcome Measures

Primary Outcomes (1)

• Change in TOF ratio after perfusion of magnesium

  This primary outcome will be assessed with neuromuscular monitoring, carried out according to international guidelines. The ulnar nerve will be stimulated by train-of-four (TOF) using a TofScan monitor.

  After starting TOF AUTO mode. patients will receive an intravenous perfusion of magnesium 60mg/kg mg kg-1 over 5 minutes. Neuromuscular monitoring will be continued until the end of surgery, but at least until a TOF ratio of 0.9 is reached.

Secondary Outcomes (1)

• Lowest T1 twitch height and TOF ratio

  After the perfusion of magnesium and until the T1 twitch height and the TOF ratio reach the initial values again.

Study Arms (4)

Propofol

ACTIVE COMPARATOR

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.

Drug: Magnesium Sulfate

Isoflurane

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

Desflurane

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

Sevoflurane

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

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; Isoflurane; Propofol; Sevoflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the consent form.
• Negative urinary or serum pregnancy test (not applicable if status post hysterectomy or tubal ligation or menopausal woman)

You may not qualify if:

• Surgery with need for neuromuscular block
• 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.

Sponsors & Collaborators

• Christoph Czarnetzki: lead
• Centre Hospitalier du Centre du Valais: collaborator
• Ospedale Regionale di Lugano: collaborator

Study Sites (1)

Department of Anesthesiology and Intensive Care, Valais Hospital

Sion, 1951, Switzerland

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Christoph Czarnetzki, MD, MBA

CONTACT

+41 091 8116664; christoph.czarnetzki@hcuge.ch

Sina Grape, MD, MBA

CONTACT

0041276038759; sina.grape@hopitalvs.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: For practical reasons it is impossible to blind the investigator who conducts the anesthesia. However, the parameters of neuromuscular block are standardized, and study outcomes will be evaluated using the data stored and displayed in theTetraGraph Viewer software. All neuromuscular measurements of the study outcomes are reproducible and objective. 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Model Details: This study is a three centers prospective randomized, electrophysiological, single blinded study that will include 96 patients allocated to one of four arms: one arm with propofol anesthesia and three arms with volatile anesthetics (one arm with isoflurane, one with sevoflurane and one with desflurane). Each arm will have 24 patients.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: March 2, 2022
• Study Start: November 18, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)