Impact of Preoperative Midazolam on Outcome of Elderly Patients (I-PROMOTE)
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|ClinicalTrials.gov Identifier: NCT03052660|
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Preanesthetic Medication||Drug: Midazolam Drug: Placebo oral capsule||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||782 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Preoperative Midazolam on Outcome of Elderly Patients: a Multicentre Randomised Controlled Trial|
|Actual Study Start Date :||October 12, 2017|
|Actual Primary Completion Date :||June 24, 2019|
|Actual Study Completion Date :||June 24, 2019|
Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
Oral administration preoperatively
Other Name: Dormicum
Placebo Comparator: Placebo
Placebo, oral, once, 30-45 minutes before surgery
Drug: Placebo oral capsule
Oral administration preoperatively
- Global patient satisfaction on the first postoperative day [ Time Frame: on the first postoperative day (1 day) ]measured with the EVAN-G questionnaire on the first postoperative day
- Cognitive testing [ Time Frame: preoperative, day 1 and day 30 after surgery (31 days) ]Measured by the short blessed test
- Delirium testing [ Time Frame: preoperative, day 1 after surgery (2 days) ]Measured by Confusion Assessment Method (CAM)
- Preoperative anxiety [ Time Frame: preoperatively (1 day) ]Measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
- Change of health-related quality of life [ Time Frame: 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 [ Time Frame: preoperative and day 30 after surgery (31 days) ]Measured by Instrumental Activities of Daily Living scale (IADL)
- Perception of pain, well-being, and sleeping [ Time Frame: preoperative until first postoperative day (3 days) ]Self-reported by visual analogue scale (VAS)
- Number of participants with adverse events and serious adverse events [ Time Frame: surgery and first postoperative day (2 days) ]Review of medical charts and patient interview
- Patient cooperation [ Time Frame: surgery day (1 day) ]Self-reported by visual analogue scale (VAS) by the attending anesthetist
- Anaesthesia related data [ Time Frame: surgery day (1 day) ]Anesthesia drugs, type of anesthesia, duration, extubation-time
- Surgery related data [ Time Frame: surgery day (1 day) ]Duration and kind of surgery
- Rescue benzodiazepine application [ Time Frame: surgery day (1 day) ]assessment of additional requirement of midazolam in the operating area
- Patients vital data [ Time Frame: surgery day (1 day) ]Measurement of SpO2, RRsys, HR on arrival in the operating room and at the end of surgery
- Mortality [ Time Frame: 30 days ]Patient chart review and telephone interview after discharge
- Major adverse events [ Time Frame: 30 days ]Assessment of postoperative major adverse cardiovascular and cerebral events by patient chart review and telephone interview after discharge
- Hospital length of stay [ Time Frame: on postoperative day 30 (1 day) ]Patient chart review
- Intensive care unit length of stay [ Time Frame: on postoperative day 30 (1 day) ]Patient chart review
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052660
|Department of Anesthesiology, University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Bonn|
|Bonn, NRW, Germany, 53127|
|Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf|
|Dusseldorf, NRW, Germany, 40225|
|Herne, Germany, 44625|
|Universitätsklinikum Magdeburg A.ö.R.|
|Magdeburg, Germany, 39120|
|Department of Anaesthesiology, University Hospital Klinikum rechts der Isar Munich|
|Munich, Germany, 81675|
|München, Germany, 81377|
|Kreiskliniken Reutlingen, Klinikum am steinenberg|
|Reutlingen, Germany, 72764|
|Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen|
|Tubingen, Germany, 72076|
|Study Chair:||Mark Coburn, Professor||Department of Anesthesiology, University Hospital Aachen, Germany|