Awake implantation of a neuromodulative system.
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexdor
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: µl/ml mi
Sponsors
Erasmus Medical Centre, Department of Anesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patient overall satisfaction. ;Secondary Objective: 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;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. 1 day post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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? ;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 | — |
Countries
Netherlands
Contacts
Public ContactProf. Dr. F.J.P.M. Huygen
Erasmus Medical Centre, Department of Anesthesiology
Outcome results
None listed