Impact of Preoperative Midazolam on Outcome of Elderly Patients

• Status: Completed
• Trial end date: 2019-06-24
• Target enrollment: 0
• Participant gender: All

Summary

We aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Midazolam

Criteria

Inclusion Criteria:

1. 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

Exclusion Criteria:

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) or investigational 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