Preanesthetic Medication
Conditions
Keywords
Midazolam, Anxiety, Clinical trial, Patient Satisfaction
Brief 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
Detailed description
Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. Particularly, in elderly patients (≥65 years), a higher risk for adverse events is described. Patients will be randomly assigned to one of the following two study groups. Preoperatively, group 1 will receive midazolam and group 2 will receive placebo. Anaesthesia will be performed according to the clinical routine. All possible side effects are described in the SmPC for midazolam. For the placebo-group, we do not expect any harm, as in the case of strong preoperative anxiety or agitation, additional midazolam application may occur on behalf of the attending anaesthesist at any time. The sample size was calculated based on detecting a minimum of 5 unit difference in the primary outcome variable overall patient satisfaction measured with the EVAN-G. Setting a type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of EVAN-G to be 14 units, 248 patients per group are needed to detect a 5 unit difference. Considering a drop-out of 10% and a screening failure of 10%, we decided to include 614 patients in total. The hypothesis of the study is that global patient satisfaction after surgery in elderly patients is similar after preoperative placebo application compared to midazolam application.
Interventions
DRUGMidazolam
Oral administration preoperatively
DRUGPlacebo oral capsule
Oral administration preoperatively
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global patient satisfaction on the first postoperative day | on the first postoperative day (1 day) | measured with the EVAN-G questionnaire on the first postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive testing | preoperative, day 1 and day 30 after surgery (31 days) | Measured by the short blessed test |
| Delirium testing | preoperative, day 1 after surgery (2 days) | Measured by Confusion Assessment Method (CAM) |
| Preoperative anxiety | preoperatively (1 day) | Measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) |
| Change of health-related quality of life | preoperative and day 30 after surgery (31 days) | Measured by the individual health-related quality of life assessment EQ-5D-5L |
| Activities of daily living | preoperative and day 30 after surgery (31 days) | Measured by Instrumental Activities of Daily Living scale (IADL) |
| Perception of pain, well-being, and sleeping | preoperative until first postoperative day (3 days) | Self-reported by visual analogue scale (VAS) |
| Number of participants with adverse events and serious adverse events | surgery and first postoperative day (2 days) | Review of medical charts and patient interview |
| Patient cooperation | surgery day (1 day) | Self-reported by visual analogue scale (VAS) by the attending anesthetist |
| Anaesthesia related data | surgery day (1 day) | Anesthesia drugs, type of anesthesia, duration, extubation-time |
| Surgery related data | surgery day (1 day) | Duration and kind of surgery |
| Rescue benzodiazepine application | surgery day (1 day) | assessment of additional requirement of midazolam in the operating area |
| Patients vital data | surgery day (1 day) | Measurement of SpO2, RRsys, HR on arrival in the operating room and at the end of surgery |
| Mortality | 30 days | Patient chart review and telephone interview after discharge |
| Major adverse events | 30 days | Assessment of postoperative major adverse cardiovascular and cerebral events by patient chart review and telephone interview after discharge |
| Hospital length of stay | on postoperative day 30 (1 day) | Patient chart review |
| Intensive care unit length of stay | on postoperative day 30 (1 day) | Patient chart review |
Countries
Germany
Outcome results
None listed