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The effects of midazolam on the quality of postoperative recovery

Putting Resistance under the Microscope II. ; A Randomized Controlled Trial on the effects of midazolam on the quality of postoperative recovery in patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003680-21-NL
Enrollment
Unknown
Registered
2012-11-07
Start date
2013-06-18
Completion date
Unknown
Last updated
2013-07-15

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

Conditions

perioperative resistance, anxiety MedDRA version: 14.1 Level: LLT Classification code 10037935 Term: Reaction anxiety System Organ Class: 100000004873

Interventions

Trade Name: Midazolam (Dormicum) Product Name: Midazolam (dormicum) Pharmaceutical Form: Intravesical solution/solution for injection INN or Proposed INN: MIDAZOLAM CAS Number: 59467-70-8 Other descri

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients >18 years, operated in the Erasmus MC, and planned to stay for minimum of 3 days in the hospital 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: Patients with psychiatric disorders which are treated with psychopharmaca. Contra-indications midazolam (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: Midazolam is frequently used as an anaesthesiological premedication before surgery in order to reduce patients resistance. Does midazolam also improve the quality of postoperative recovery?;Secondary Objective: Is there a rebound effect? This is described and found in previous studies. Patients who get a benzodiazepine are more vulnerable and show more resistance than patients who don't get a benzodiapine;Primary end point(s): quality of recovery, aggression, anxiety, fatigue, depression;Timepoint(s) of evaluation of this end point: preoperative, 1st day postoperative, third day postoperative, 7th day postoperative—

Secondary

MeasureTime frame
Secondary end point(s): rebound effect;Timepoint(s) of evaluation of this end point: see timepoints primary end points—

Countries

Netherlands

Contacts

Public ContactStefan van Beek

Erasmus MC

s.vanbeek@erasmusmc.nl+31640390422

Outcome results

None listed

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