The effects of midazolam on the quality of postoperative recovery
- Conditions
- MedDRA version: 14.1Level: LLTClassification code 10037935Term: Reaction anxietySystem Organ Class: 100000004873Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]perioperative resistance, anxiety
- Registration Number
- EUCTR2012-003680-21-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): rebound effect;Timepoint(s) of evaluation of this end point: see timepoints primary end points