Study of the hypnotic and anti-nociceptive components of Magnesium using Electroencephalogram Spectral Entropy and pupillometry during total intravenous general anesthesia

Study of the hypnotic and anti-nociceptive components of Magnesium using Electroencephalogram Spectral Entropy and pupillometry during total intravenous general anesthesia : a randomized double-blind placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002824-19-BE

Enrollment

Registered

2021-07-28

Start date

2021-08-12

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total thyroidectomy

Interventions

Trade Name: Magnesium Sulfate Sterop Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Magnesium sulphate CAS Number: 10034-99-8 Other descriptive name: MAGNESI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18–95 years, American Society of Anesthesiologists Physical Status I–III, scheduled for elective thyroidectomy at CHU of Liège. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Participants will be excluded if they had a heart failure with left ventricular ejection fraction < 35%, renal insufficiency (creatinine clearance < 40 mL/min), neuromuscular diseases or atrioventricular block.

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study we primarily aimed at evaluating the influence of magnesium sulphate injection on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anesthesia. The primary endpoint will be the target concentration of Propofol TCI to achieve a state entropy value between 50-60.;Secondary Objective: Secondary end points were PPI 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; the PRD during laryngoscopy maintained for 30 sec, surgical incision and 10min after surgical incision.;Primary end point(s): The primary endpoint will be the target concentration of Propofol TCI to achieve a state entropy value between 50-60.;Timepoint(s) of evaluation of this end point: The target concentration of Propofol (TCI) to achieve a state entropy value between 50-60 (primary endpoint). State Entropy and Response Entropy values before anesthesia and then every 2.5 minutes until 10 min after surgical incision.	—

Measure

Time frame

Main Objective: In this study we primarily aimed at evaluating the influence of magnesium sulphate injection on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anesthesia. The primary endpoint will be the target concentration of Propofol TCI to achieve a state entropy value between 50-60.;Secondary Objective: Secondary end points were PPI 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; the PRD during laryngoscopy maintained for 30 sec, surgical incision and 10min after surgical incision.;Primary end point(s): The primary endpoint will be the target concentration of Propofol TCI to achieve a state entropy value between 50-60.;Timepoint(s) of evaluation of this end point: The target concentration of Propofol (TCI) to achieve a state entropy value between 50-60 (primary endpoint). State Entropy and Response Entropy values before anesthesia and then every 2.5 minutes until 10 min after surgical incision.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints were the evaluation of PPI before endotracheal intubation, PRD during laryngoscopy and surgical incision, morphine consumption in the recovery room and total morphine consumption at day-1, incidence of side effects related to morphine consumption at day-1, such as postoperative nausea and vomiting.;Timepoint(s) of evaluation of this end point: Before endotracheal intubation, PRD during laryngoscopy and surgical incision. Morphine consumption in the recovery room and total morphine consumption at day-1, incidence of side effects related to morphine consumption at day-1, such as postoperative nausea and vomiting.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints were the evaluation of PPI before endotracheal intubation, PRD during laryngoscopy and surgical incision, morphine consumption in the recovery room and total morphine consumption at day-1, incidence of side effects related to morphine consumption at day-1, such as postoperative nausea and vomiting.;Timepoint(s) of evaluation of this end point: Before endotracheal intubation, PRD during laryngoscopy and surgical incision. Morphine consumption in the recovery room and total morphine consumption at day-1, incidence of side effects related to morphine consumption at day-1, such as postoperative nausea and vomiting.

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Countries

Belgium

Contacts

Public ContactPierre-Yves Hardy

CHU de Liège

pyhardy@chuliege.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026