Hypnotic and Anti-nociceptive Components of Magnesium

Anesthesia Clinical Trial

Official title:

Study of the Hypnotic and Anti-nociceptive Components of Magnesium Using Electroencephalogram Spectral Entropy and Pupillometry During Total Intravenous General Anaesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05005494
• Other study ID #: MG-Entropy
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2021
• Source: University of Liege
• Contact: Pierre-Yves Hardy, MD
• Phone: 003242844858
• Email: pyhardy[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.

Description:

The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol. To achieve this, the investigators will analyse the effect of magnesium on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anaesthesia. Our study will also evaluate the intraoperative anti- nociceptive effect of magnesium using pupillometry and its two indices, PPI and PRD

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult > 18 years

• Patients of both sexes

• Any patient scheduled for thyroidectomy at the University Hospital of Liege

Exclusion Criteria:

• Heart failure with left ventricular ejection fraction < 35

• Renal insufficiency (clearance < 40 mL/min)

• Neuromuscular diseases

• Atrioventricular block

• Pregnancy

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Magnesium sulfate IV
Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)
• Placebo
Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)

Locations

Country	Name	City	State
Belgium	CHU Liege,	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol target concentration	The target concentration of Propofol TCI (target-control infusion) to achieve a state entropy value between 50-60	through study completion, an average of 3 months
Secondary	Morphine consumption	Morphine consumption titrated in the recovery room and morphine equivalents claimed during the first 24 hours postoperatively	through study completion, an average of 3 months
Secondary	PPI Measure	PPI (pupillary pain index) by pupillometry with "AlgiScan®" monitoring, before endotracheal intubation and with a State Entropy of 50-60, then every 5 min between endotracheal intubation and surgical incision	through study completion, an average of 3 months
Secondary	PRD Measure	PRD (pupillary reflex dilatation) during laryngoscopy maintained for 30 sec, surgical incision and 10min after surgical incision	through study completion, an average of 3 months