The purpose of this study is to observe the usability of Dexmedetomidine and to determine the overall satisfaction of the patient.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is overall patient satisfaction measured by a
questionnaire.
Secondary outcome
The secundary study parameters:
- Sedation scale (Ramsey score),
- Clinical pain relief (NRS score),
- Patient comfort score and operator comfort score
- Hemodynamic measuring (blood pressure and heart rate)
- Respiratory frequency measuring (capnography) and pulsoximetry.
- Measurement of the number of adjustments of Dexmedetomidine titration during
procedure
Background summary
Dexmedetomidine has proven to be a good sedative in several diagnostic and
therapeutic *awake* procedures. We want to observe the usefulness of
Dexmedetomidine in the awake implantation of a neuromodulative system. This is
a painful procedure, which can be uncomfortable due to the long-term prone
position. Deep sedation is undesirable because the patients have to be
cooperative during the procedure.
Compared to commonly used sedatives and analgesics, such as remifentanil and
propofol, Dexmedetomidine appears to be hemodynamically and respiratory safer,
more comfortable for the patient while at the same time it is possible for the
patient to be fully cooperative.
Study objective
The purpose of this study is to observe the usability of Dexmedetomidine and to
determine the overall satisfaction of the patient.
Study design
This is a prospective observational study with an intervention.
Intervention
Loading infusion of the sedative Dexmedetomidine.
Study burden and risks
The potential benefits of the use of Dexmedetomidine during procedure include
no blur of consciousness; no decline of cognitive skills; the patient is
required less alert, is sleeping but still arousable, cooperative and instruct
able without any agitation. Dexmedetomidine has a good anxiolytic effect, a
light analgesic effect and causes no respiratory depression. It makes a lower
dose of propofol and remifentanil possible. Side effects are the possibility of
hypotension and bradycardia. A disadvantage is that is has no amnesic effects.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
- Patients need to be between 18 and 65 years.;- Patients have an indication for implantation of a neuromodulative system.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001587-35-NL |
| CCMO | NL49012.078.14 |