E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Awake implantation of a neuromodulative system. |
De wakkere implantatie van een neuromodulatief systeem. |
|
E.1.1.1 | Medical condition in easily understood language |
The implantation of a neurostimulator in an awake patient. |
De plaatsing van een neurostimulator bij een wakkere patient. |
|
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 |
Patient overall satisfaction. |
Algemene patient tevredenheid. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess clinical usefulness of
Dexmedetomidine on
- Hemodynamics (bloodpressure and heart rate),
- Respiration (capnography and pulse oximetry),
- Ramsey sedation scores,
- Pain relief (NRS score),
- Patient comfort score and operator comfort score,
- The measurement of the number of adjustments of Dexmedetomidine titration
- Measurement of number of (extra) bolus of remifentanil during procedure |
De secundaire uitkomstmaten zijn:
- Sedatie score (Ramsey)
- Pijn score (NRS score)
- Hemodynamische uitkomstmaten (bloeddruk en hartslag)
- Respiratoire uitkomstmaten (capnografie en pulsoxymetrie)
- Patient comfort score en operateur comfort score.
- Meten van het aantal aanpassingen van Dexmedetomidine titratie tijdens de procedure
- Meten van aantal extra bolussen van remifentanil tijdens de procedure |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients need to be betweem 18 and 65 years
-Patients have an indication for implantation of a neuromodulative system |
- Patienten moeten tussen 18 en 65 jaar zijn
-Patienten met een indicatie voor implantatie van een neurmodulatief systeem |
|
E.4 | Principal exclusion criteria |
- Hypersensitivity of active part of one of any of the excipients
- AV-blok (II or III)
- Acute cerebrovascular disease
- Pregnancy
- Acute epilepsy
- Severe liver dysfunction
- Use of a beta blocker
- Psychologically unstable
- Communication problem
- Heart rate <60bpm
- Allergy for soya or peanuts
- Heart failure
- Severe heart disease
- Electroconvulsive therapy (ECT)
- ASA III, IV, V
|
- Hypersensitiviteit van het actieve deel van Dexmedetomidine
- AV-blok (II of III)
- Acute cerebrovasculaire ziekte
- Zwangerschap
- Acute epilepsie
- Ernstige leverdysfunctie
- Gebruik van een beta blokker
- Psychisch instabiel
- Communicatie probleem
- Hartslag <60
- Allergie voor soja of pinda's
- Hartfalen
- Ernstige hartziekte
- Elektroconvulsieve therapie (ECT)
- ASA III, IV, V |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Does dexmedetomidine or propofol give a higher patient overall satisfaction in awake implantation of neurmodulative systems? |
Geeft dexmedetomidine of propofol een hogere patient tevredenheid bij de wakkere implantatie van een neuromodulatief systeem? |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes post-operative.
1 day post-operative. |
30 minuten post-operatief
1 dag post-operatief. |
|
E.5.2 | Secondary end point(s) |
Does Dexmedetomidine compared to propofol improve sedation and improve patient comfort and operator comfort? Does dexmedetomidine compared to propofol decrease the clinical pain score and will dexmedetomidine compared to propofol take care of a good control of the hemodynamic and respiratory values? |
Verbetert dexmedetomidine vergeleken met propofol de sedatie en verbetert dexmedetomidine vergeleken met propofol het comfort van de patient en het comfort van de operateur? Zal dexmedetomidine vergeleken met propofol de klinische pijnscore laten dalen en zal er goede controle mogelijk zijn van de hemodynamische en respiratoire waarden? |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 5 - 10 - 20 - 30 minutes during procedure after a step:
Steps:
- Baseline
- Start Dexmedetomidine infusion
- Start Analgetic infusion (Remifentanil)
- Start of Procedure
- Time of median incision
- End of procedure
- Post operative |
Elke 5 - 10 - 20 - 30 minuten tijdens de operatie na een stap.
Stappen:
- Baseline
- Start Dexmedetomidine infuus
- Start Analgetische infuus (Remifentanil)
- Start operatie
- Tijdstip van mediane incisie
- Einde van operatie
- Post operatief |
|
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 |
Patient overall satisfaction |
Algemene patient tevredenheid |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |