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

Dexmedetomidine versus propofol in awake implantation of a neuromodulative system. - DexMedPro

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000964-33-NL

Enrollment

Registered

2015-07-13

Start date

2015-09-17

Completion date

Unknown

Last updated

2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake implantation of a neuromodulative system.

Interventions

Trade Name: Dexdor Product Name: Dexdor Product Code: N05Cm18 Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 11

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

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 - 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. 1 day post-operative.	—

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 - 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. 1 day post-operative.

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Secondary

Measure	Time frame
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: Steps: - Baseline - Start Dexmedetomidine infusion - Start Analgetic infusion (Remifentanil) - Start of Procedure - Time of median incision - End of procedure - Post operative	—

Measure

Time frame

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: Steps: - Baseline - Start Dexmedetomidine infusion - Start Analgetic infusion (Remifentanil) - Start of Procedure - Time of median incision - End of procedure - Post operative

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Countries

Netherlands

Contacts

Public ContactProf. Dr. F.J.P.M. Huygen

Erasmus Medical Center, Department of Anesthesiology

f.huygen@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026