Dexmedetomidine versus propofol during the implantation of a neurostimulator in awake patients.

Phase 1

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

Registration Number: EUCTR2015-000964-33-NL

Lead Sponsor: Erasmus Medical Center, Department of Anesthesiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

- Patients need to be betweem 18 and 65 years
-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 74
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-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

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.;Secondary Objective: Secondary objectives are to assess clinical usefulness of<br>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<br>- Measurement of number of (extra) bolus of remifentanil during procedure;Primary end point(s): Does dexmedetomidine or propofol give a higher 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 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? ;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>- Post operative