Hypnotic and Anti-nociceptive Components of Magnesium

NCT ID: NCT05005494

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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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

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded prospective randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patient, anesthesiologist and surgeon are blinded

Study Groups

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Magnesium sulfate IV

10 patients scheduled for thyroidectomy

Group Type ACTIVE_COMPARATOR

Magnesium sulfate IV

Intervention Type DRUG

Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)

Placebo

10 patients scheduled for thyroidectomy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)

Interventions

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Magnesium sulfate IV

Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)

Intervention Type DRUG

Placebo

Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Head of Anesthesiology Departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Liege,

Liège, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Pierre-Yves Hardy, MD

Role: CONTACT

003242844858

Other Identifiers

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MG-Entropy

Identifier Type: -

Identifier Source: org_study_id

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