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Putting Resistance under the Microscope. (Weerstand onder de Loep) - perioperative resistance

Putting Resistance under the Microscope. (Weerstand onder de Loep) - perioperative resistance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020332-19-NL
Enrollment
Unknown
Registered
2010-06-07
Start date
2010-08-23
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Patients resistance concerning diagnostic or therapeutic procedure are well known. In this trial patients-resistance during the perioperative period will be investigated in day-case-surgery. Features of the perioperative resistance of patients are medical conditions (like, heart rate, blood pressure, PONV, pain) and psychological conditions (like anxiety, fatigue, agression, complaints of depression). MedDRA version: 12.1 Level: LLT Classification code 10002865 Term: Anxiety reaction

Interventions

Trade Name: TEMESTA Product Name: TEMESTA Product Code: E0721BHN01Z0N Pharmaceutical Form: Injection* INN or Proposed INN: Lorazepam CAS Number: 846-49-1 Current Sponsor code: E0721BHN01Z0N Other desc

Sponsors

ERASMUS MC, Dept Anesthesiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients of day case surgery, age =18 years. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with psychiatric disorders which are treated with psychopharmaca. Contra-indications lorazepam (like myasthenia gravis, severe liver insufficiency). Patients which give no informed consent and patients with a language barrier.

Design outcomes

Primary

MeasureTime frame
Main Objective: Lorazepam is frequently used as an anaesthesiological premedication before surgery in order to reduce patients resistance. Does lorazepam also improve the quality of recovery in patients scheduled for day-case-surgery?;Secondary Objective: Developping a prognostic model, which tells us which patients are vulnerable and/or need (lorazepam as) premedication before surgery. And what is the influence of the pharmacogenetic background of lorazepam on this model?;Primary end point(s): Quality of recovery, aggression, anxiety, fatigue, depression symptoms—

Countries

Netherlands

Outcome results

None listed

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