A Phase 4 interventional study of Midazolam and Placebo oral capsule in Preanesthetic Medication, sponsored by RWTH Aachen University. Completed at 9 sites in Germany. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by RWTH Aachen University · Phase 4, Interventional, and Treatment
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
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.
RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
Drug: Midazolam
Placebo, oral, once, 30-45 minutes before surgery
Drug: Placebo oral capsule
Oral administration preoperatively
Also known as: Dormicum
Oral administration preoperatively
Global patient satisfaction on the first postoperative day
measured with the EVAN-G questionnaire on the first postoperative day
Time frame: on the first postoperative day (1 day)
Cognitive testing
Measured by the short blessed test
Time frame: preoperative, day 1 and day 30 after surgery (31 days)
Delirium testing
Measured by Confusion Assessment Method (CAM)
Time frame: preoperative, day 1 after surgery (2 days)
Preoperative anxiety
Measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: preoperatively (1 day)
Change of health-related quality of life
Measured by the individual health-related quality of life assessment EQ-5D-5L
Time frame: preoperative and day 30 after surgery (31 days)
Activities of daily living
Measured by Instrumental Activities of Daily Living scale (IADL)
Time frame: preoperative and day 30 after surgery (31 days)
Perception of pain, well-being, and sleeping
Self-reported by visual analogue scale (VAS)
Time frame: preoperative until first postoperative day (3 days)
Number of participants with adverse events and serious adverse events
Review of medical charts and patient interview
Time frame: surgery and first postoperative day (2 days)
Patient cooperation
Self-reported by visual analogue scale (VAS) by the attending anesthetist
Time frame: surgery day (1 day)
Anaesthesia related data
Anesthesia drugs, type of anesthesia, duration, extubation-time
Time frame: surgery day (1 day)
Surgery related data
Duration and kind of surgery
Time frame: surgery day (1 day)
Rescue benzodiazepine application
assessment of additional requirement of midazolam in the operating area
Time frame: surgery day (1 day)
Patients vital data
Measurement of SpO2, RRsys, HR on arrival in the operating room and at the end of surgery
Time frame: surgery day (1 day)
Mortality
Patient chart review and telephone interview after discharge
Time frame: 30 days
Major adverse events
Assessment of postoperative major adverse cardiovascular and cerebral events by patient chart review and telephone interview after discharge
Time frame: 30 days
Hospital length of stay
Patient chart review
Time frame: on postoperative day 30 (1 day)
Intensive care unit length of stay
Patient chart review
Time frame: on postoperative day 30 (1 day)
Plan to share: No
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RWTH Aachen University