Hypnotic and Anti-nociceptive Components of Magnesium

August 13, 2021 updated by: Jean François Brichant, University of Liege

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • CHU Liege,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium sulfate IV
10 patients scheduled for thyroidectomy
Drug: Magnesium sulfate IV
Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)
Placebo Comparator: Placebo
10 patients scheduled for thyroidectomy
Drug: Placebo
Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol target concentration
Time Frame: through study completion, an average of 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: through study completion, an average of 3 months
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
PPI Measure
Time Frame: through study completion, an average of 3 months
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
PRD Measure
Time Frame: through study completion, an average of 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG-Entropy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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