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Dexmedetomidine PKPD and effect of stimulation

Development of a pharmacokinetic/pharmacodynamic model of dexmedetomidine, and the effect of repeated auditory stimulation on pharmacodynamics of dexmedetomidine

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005443-24-NL
Enrollment
Unknown
Registered
2012-12-13
Start date
2013-03-05
Completion date
Unknown
Last updated
2013-04-01

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

Conditions

To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.

Interventions

Product Name: dexemedetomidine Product Code: DB00633 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: dexmedetomidine CAS Number: 145108-58-3 Other

Sponsors

UMCG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) Physical Status 1 No medical history of significance No chronic use of medication, alcohol, drugs or tobacco (oral contraceptives excluded). 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Contraindications for use of dexmedetomidine - Known intolerance to dexmedetomidine - Body mass index (BMI) 35 kg/m2 - Volunteer refusal - Pregnancy, or currently nursing

Design outcomes

Primary

MeasureTime frame
Main Objective: To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.;Secondary Objective: NA;Primary end point(s): Development of a pharmacokinetic/pharmacodynamic (PKPD) model for dexmedetomidine. For this purpose, we will gather PK-data (amount of dexmedetomidine infused at 10 second intervals, arterial dexmedetomidine plasma concentrations), and PD-data (BIS, OAA/S score), for use in model development.;Timepoint(s) of evaluation of this end point: end of study day—

Secondary

MeasureTime frame
Secondary end point(s): The effect of stimulation on dexmedetomidine pharmacodynamics (ke0) (derived from the PKPD-model) and BIS. For the pharmacodynamic part of the haemodynamic PKPD model, cardiac output, cardiac index and systemic vascular resistence will be recorded. ;Timepoint(s) of evaluation of this end point: end of study day—

Countries

Netherlands

Contacts

Public Contactresearch desk

UMCG

r.spanjersberg@umcg.nl0031503611158

Outcome results

None listed

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