Hypnotic and Anti-nociceptive Components of Magnesium

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Placebo; Drug: Magnesium sulfate IV

• Registration Number: NCT05005494
• Lead Sponsor: University of Liege

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-13
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19
• Study Start: 2021-09-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	10 patients scheduled for thyroidectomy
Magnesium sulfate IV	Magnesium sulfate IV	10 patients scheduled for thyroidectomy

Primary Outcome Measures

Name	Time	Method
Propofol target concentration	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

Secondary Outcome Measures

Name	Time	Method
Morphine consumption	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
PPI Measure	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
PRD Measure	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

Trial Locations

Locations (1)

CHU Liege,; 🇧🇪 Liège, Belgium