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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

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE October 12, 2017
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • 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)
  • Quality of Life [ Time Frame: preoperative and day 30 after surgery (31 days) ]
    Measured by the 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Preoperative Midazolam on Outcome of Elderly Patients
Official Title  ICMJE Impact of Preoperative Midazolam on Outcome of Elderly Patients: a Multicentre Randomised Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Preanesthetic Medication
Intervention  ICMJE
  • Drug: Midazolam
    Oral administration preoperatively
    Other Name: Dormicum
  • Drug: Placebo oral capsule
    Oral administration preoperatively
Study Arms  ICMJE
  • Experimental: Midazolam
    Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
    Intervention: Drug: Midazolam
  • Placebo Comparator: Placebo
    Placebo, oral, once, 30-45 minutes before surgery
    Intervention: Drug: Placebo oral capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2019)
782
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
614
Actual Study Completion Date  ICMJE June 24, 2019
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03052660
Other Study ID Numbers  ICMJE 16-115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RWTH Aachen University
Study Sponsor  ICMJE RWTH Aachen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mark Coburn, Professor Department of Anesthesiology, University Hospital Aachen, Germany
PRS Account RWTH Aachen University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP