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 |
Secundaire parameters zijn het beoordelen van het klinische nut van Dexmedetomidine door:
- Hemodynamische meting (bloeddruk en hartslag)
- Respiratoire meting (capnografie en pulse oxymetrie)
- Ramsey sedatie score
- Pijn score (NRS score)
- Patient comfort score en operateur comfort score
- Het meten van het aantal aanpassingen van Dexmedetomidine titratie |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients need to be 18 years or older
-Patients have an indication for implantation of a neuromodulative system. |
- Patienten moeten ouder dan 18 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-block (II or III)
- Acute cerebrovascular disease
- Pregnancy
- Acute epilepsy
- Severe liver dysfunction
- Use of a beta blocker.
- Psychologically unstable
- Communication problem. |
- 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Does Dexmedetomidine improve the patient overall satisfaction in awake implantation of neurmodulative systems? |
Verbetert Dexmedetomidine de algemene patient tevredenheid tijdens implantatie van neurmodulatieve systemen bij wakkere patienten? |
|
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 improve sedation and improve patient comfort and operator comfort? Does Dexmedetomidine decrease the clinical pain score and will Demedetomidine take care of a good control of the hemodynamic and respiratory values?
|
Verbetert Dexmedetomidine de sedatie en verbetert Dexmedetomidine het comfort van de patient en het comfort van de operateur? Zal Dexmedetomidine 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
- 1 day after procedure |
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
- 1 dag na operatie |
|
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 | No |
E.8.1.1 | Randomised | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
|
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 | |