Anesthesia
Conditions
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
Interventions
DRUGMagnesium sulfate IV
Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)
DRUGPlacebo
Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patient, anesthesiologist and surgeon are blinded
Intervention model description
Double blinded prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactPierre-Yves Hardy, MD
Outcome results
None listed