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Validation of the Eleveld remimazolam PK/PD model

External validation study for the Eleveld remimazolam pharmacokinetic-pharmacodynamic model - External validation study for the Eleveld remimazolam pharmacokinetic-pharmacodynamic model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61304
Enrollment
75
Registered
2025-08-19
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

narcosis and sleepmedication narcosis and sleepmedication

Interventions

The Eleveld PKPD model. The Eleveld PKPD model predicts the initial dose and infusion rate of remimazolam for maintaining general anaesthesia and sedation, based on general parameters such as height,

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age = 18 yearsAmerican Society of Anesthesiologists (ASA) physical status 1-3Elective surgical procedure of >1 hour expected durationNeed for an arterial line placement for the procedureWritten informed consent

Exclusion criteria

Exclusion criteria: Contraindication for the use of remimazolam (e.g. allergy, unstable myasthenia gravis, or pregnancy)Inclusion in other studies preventing the use of remimazolam as primary hypnotic agentPatients taking other sedatives/hypnotics prior to administration of remimazolamPatients who have been admitted to the intensive care unit prior to surgery and/or have received remimazolam as sedation or anaesthesia in the 24 hours before the study

Design outcomes

Primary

MeasureTime frame
Performance criteria (performance error, median (absolute) performance error, divergence, wobble) assessing the performance of the Eleveld PKPD model in the studied population.

Countries

Netherlands

Contacts

Public ContactM.M.R.F. Struys

Universitair Medisch Centrum Groningen

m.m.r.f.struys@umcg.nl0503616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026