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Impact of Preoperative Midazolam on Outcome of Elderly Patients (I-PROMOTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052660
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Preanesthetic Medication Drug: Midazolam Drug: Placebo oral capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Midazolam
Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
Drug: Midazolam
Oral administration preoperatively
Other Name: Dormicum

Placebo Comparator: Placebo
Placebo, oral, once, 30-45 minutes before surgery
Drug: Placebo oral capsule
Oral administration preoperatively




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cognitive testing [ Time Frame: preoperative, day 1 and day 30 after surgery (31 days) ]
    Measured by the short blessed test

  2. Delirium testing [ Time Frame: preoperative, day 1 after surgery (2 days) ]
    Measured by Confusion Assessment Method (CAM)

  3. Preoperative anxiety [ Time Frame: preoperatively (1 day) ]
    Measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  4. 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

  5. Activities of daily living [ Time Frame: preoperative and day 30 after surgery (31 days) ]
    Measured by Instrumental Activities of Daily Living scale (IADL)

  6. Perception of pain, well-being, and sleeping [ Time Frame: preoperative until first postoperative day (3 days) ]
    Self-reported by visual analogue scale (VAS)

  7. 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

  8. Patient cooperation [ Time Frame: surgery day (1 day) ]
    Self-reported by visual analogue scale (VAS) by the attending anesthetist

  9. Anaesthesia related data [ Time Frame: surgery day (1 day) ]
    Anesthesia drugs, type of anesthesia, duration, extubation-time

  10. Surgery related data [ Time Frame: surgery day (1 day) ]
    Duration and kind of surgery

  11. Rescue benzodiazepine application [ Time Frame: surgery day (1 day) ]
    assessment of additional requirement of midazolam in the operating area

  12. 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

  13. Mortality [ Time Frame: 30 days ]
    Patient chart review and telephone interview after discharge

  14. 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

  15. Hospital length of stay [ Time Frame: on postoperative day 30 (1 day) ]
    Patient chart review

  16. Intensive care unit length of stay [ Time Frame: on postoperative day 30 (1 day) ]
    Patient chart review



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Germany
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
Marien-Hospital Herne
Herne, Germany, 44625
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany, 39120
Department of Anaesthesiology, University Hospital Klinikum rechts der Isar Munich
Munich, Germany, 81675
LMU München
München, Germany, 81377
Kreiskliniken Reutlingen, Klinikum am steinenberg
Reutlingen, Germany, 72764
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen
Tubingen, Germany, 72076
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Study Chair: Mark Coburn, Professor Department of Anesthesiology, University Hospital Aachen, Germany
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03052660    
Other Study ID Numbers: 16-115
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
Midazolam
Anxiety
Clinical trial
Patient Satisfaction
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action