Dexmedetomidine during the implantation of a neurostimulator in awake patients.

Conditions: Awake implantation of a neuromodulative system.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-001587-35-NL

Lead Sponsor: Erasmus Medical Centre, Department of Anesthesiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patients need to be 18 years or older
-Patients have an indication for implantation of a neuromodulative system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Patient overall satisfaction. <br><br><br>;Secondary Objective: Secondary objectives are to assess clinical usefulness of Dexmedetomidine on<br>- Hemodynamics (bloodpressure and heart rate),<br>- Respiration (capnography and pulse oximetry),<br>- Ramsey sedation scores, <br>- Pain relief (NRS score),<br>- Patient comfort score and operator comfort score,<br>- The measurement of the number of adjustments of Dexmedetomidine titration;Primary end point(s): Does Dexmedetomidine improve the patient overall satisfaction in awake implantation of neurmodulative systems? ;Timepoint(s) of evaluation of this end point: 30 minutes post-operative.<br>1 day post-operative.

Secondary Outcome Measures

Name	Time	Method
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?<br><br>;Timepoint(s) of evaluation of this end point: Every 5 - 10 - 20 - 30 minutes during procedure after a step.<br>Steps:<br>- Baseline<br>- Start Dexmedetomidine infusion<br>- Start Analgetic infusion (Remifentanil)<br>- Start of Procedure<br>- Time of median incision<br>- End of procedure<br>- 1 day after procedure