Impact of the midazolam, which was applied for calming before surgery, on the outcome after surgery of elderly patients. This is a randomised controlled trial, which is conducted in several hospitals in Germany.
- Conditions
- nder investigation are elderly patients (=65 years of age) undergoing each kind of surgery with planned general or combined regional and general anaesthesia. Primary, we will investigate the postoperative global patient satisfaction, depending on the kind of premedication (midazolam vs. placebo) of these patients.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-004555-79-DE
- Lead Sponsor
- RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 614
1.Only legally competent patients
2.Written informed consent prior to study participation
3.65-80 years
4.Elective surgery
5.Expected surgery duration = 30 minutes
6.Planned general or combined regional and general anaesthesia
7.Planned extubation at the end of surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 614
1.Age > 80 years
2.Age < 65 years
3.Non-fluency in German language
4.Alcohol and/ or drugs abuse
5.Chronic benzodiazepine treatment
6.Intracranial surgery
7.Local and stand by anaesthesia or solely regional anaesthesia
8.Monitored anaesthesia care
9.Cardiac surgery
10.Ambulatory surgery
11.Repeated surgery
12.Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
13. Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) orinvestigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine)
14.Expected benzodiazepine requirement after surgery
15.Expected continuous mandatory ventilation after surgery
16.Patients who explicitly request anxiolytic premedication
17.Patients with severe neurological or psychiatric disorders
18.Refusal of study participation by the patient
19.Parallel participation in interventional clinical studies within the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method