E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18–95 years, American Society of Anesthesiologists Physical Status I–III, scheduled for elective thyroidectomy at CHU of Liège. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the target concentration of Propofol TCI to achieve a state entropy value between 50-60. |
|
E.5.1.1 | 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.
|
|
E.5.2 | 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. |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
The originality of our study is that it is the first randomized superiority trial concerning magnesium sulfate infusion regarding its hypnotic component. If the hypothesis proves to be true, we could improve the hypnotic drugs sparing during total intravenous general anesthesia for total thyroidectomy. |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is reached at the last visit of the last subject at the day 2 after surgery |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |