E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seventy patients with an ASA score of I to III, 18 to 80 years old, scheduled for routine anterior cervical spine surgery in the Centro Hospitalar do Porto will be enrolled. |
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E.1.1.1 | Medical condition in easily understood language |
Seventy patients with an ASA score of I to III, 18 to 80 years old, scheduled for routine anterior cervical spine surgery in the Centro Hospitalar do Porto will be enrolled. |
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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 |
The primary objective of this study is to assess if the use of deep neuromuscular blockade reversed with sugammadex, and the consequent suppression of the EMG activity, can improve the overall stability of an anesthetic procedure (guided using BIS monitoring) and allow a reduction in the amount of anesthetic drugs required for adequate anesthesia. The primary hypothesis is that there is a better anesthetic stability in the deep NMB group (Group 2) and that this is translated as a reduction of the BIS signal variability and a reduction in the required effect-site concentrations of propofol and remifentanil (representative of the total drug consumption). |
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E.2.2 | Secondary objectives of the trial |
As a secondary objective, we will study the quality of recovery using the PQRS scale to see if maintaining a deep NMB level during surgery has an impact on the patients’ quality of recovery. The secondary hypothesis is that the quality of recovery (PQRS test) is better in the patients of Group 2.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients ASA I-III 2. Between 18 – 80 years old 3. Scheduled for routine cervical surgery 4. Minimum duration of surgery is 90 minutes and performed with total intravenous anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the neuromuscular relaxant rocuronium 5. Patients that are able to and do provide a signed informed consent form
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E.4 | Principal exclusion criteria |
1. Patients with neuromuscular diseases and severe cardiac and respiratory pathologies 2. Contra indication for any of the drugs used 3. Not able to complete the baseline PQRS test. 4. Indication to perform tracheal intubation using fibroscopy 5. Patients who are pregnant or nursing
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E.5 End points |
E.5.1 | Primary end point(s) |
• BIS signal variability using the measured standard deviation during the maintenance phase of anesthesia • Required effect-site concentrations of remifentanil and propofol
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• PQRS results at 15 and 40 minutes after surgery (taking into account the patient baseline values of the PQRS test done on the pre-anesthetic visit) • PQRS results at day 3 after surgery
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
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End of trial is after the inclusion and treatment of all 70 subjects - LVLS. |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | |