Dexmedetomidine in awake implantation of neuromodulative systems.

Phase 2

Completed

• Conditions: Awake implantation of a neuromodulative system.; 10041543

• Registration Number: NL-OMON41067
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is overall patient satisfaction measured by a<br /><br>questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary study parameters:<br /><br>- Sedation scale (Ramsey score),<br /><br>- Clinical pain relief (NRS score),<br /><br>- Patient comfort score and operator comfort score<br /><br>- Hemodynamic measuring (blood pressure and heart rate)<br /><br>- Respiratory frequency measuring (capnography) and pulsoximetry.<br /><br>- Measurement of the number of adjustments of Dexmedetomidine titration during<br /><br>procedure</p><br>