NCT03052660

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
782

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

February 7, 2017

Last Update Submit

November 14, 2019

Conditions

Preanesthetic Medication

Keywords

MidazolamAnxietyClinical trialPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Global patient satisfaction on the first postoperative day

    measured with the EVAN-G questionnaire on the first postoperative day

    on the first postoperative day (1 day)

Secondary Outcomes (16)

  • Cognitive testing

    preoperative, day 1 and day 30 after surgery (31 days)

  • Delirium testing

    preoperative, day 1 after surgery (2 days)

  • Preoperative anxiety

    preoperatively (1 day)

  • Change of health-related quality of life

    preoperative and day 30 after surgery (31 days)

  • Activities of daily living

    preoperative and day 30 after surgery (31 days)

  • +11 more secondary outcomes

Study Arms (2)

Midazolam

EXPERIMENTAL

Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery

Drug: Midazolam

Placebo

PLACEBO COMPARATOR

Placebo, oral, once, 30-45 minutes before surgery

Drug: Placebo oral capsule

Interventions

MidazolamDRUG

Oral administration preoperatively

Also known as: Dormicum
Midazolam
Placebo oral capsuleDRUG

Oral administration preoperatively

Placebo

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \. Only legally competent patients
  • Written informed consent prior to study participation
  • years
  • Elective surgery
  • Expected surgery duration ≥ 30 minutes
  • Planned general or combined regional and general anaesthesia
  • Planned extubation at the end of surgery

You may not qualify if:

  • Age \> 80 years
  • Age \< 65 years
  • Non-fluency in German language
  • Alcohol and/ or drugs abuse
  • Chronic benzodiazepine treatment
  • Intracranial surgery
  • Local and stand by anaesthesia or solely regional anaesthesia
  • Monitored anaesthesia care
  • Cardiac surgery
  • Ambulatory surgery
  • Repeated surgery
  • Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
  • 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).
  • Expected benzodiazepine requirement after surgery
  • Expected continuous mandatory ventilation after surgery
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Marien-Hospital Herne

Herne, 44625, Germany

Location

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, 39120, Germany

Location

Department of Anaesthesiology, University Hospital Klinikum rechts der Isar Munich

Munich, 81675, Germany

Location

LMU München

München, 81377, Germany

Location

Kreiskliniken Reutlingen, Klinikum am steinenberg

Reutlingen, 72764, Germany

Location

Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Related Publications (6)

  • Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.

    PMID: 15915023RESULT

  • American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults. J Am Geriatr Soc. 2015 Jan;63(1):142-50. doi: 10.1111/jgs.13281. Epub 2014 Dec 12.

    PMID: 25495432RESULT

  • Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

    PMID: 25734733RESULT

  • Kowark A, Keszei AP, Schneider G, Pilge S, Schneider F, Obert DP, Georgii MT, Heim M, Rossaint R, Ziemann S, van Waesberghe J, Czaplik M, Puhringer FK, Minarski C, May V, Malisi T, Drexler B, Ring CM, Engler P, Tilly R, Bischoff P, Frey U, Wittmann M, Soehle M, Saller T, Kienbaum P, Kretzschmar M, Coburn M; I-PROMOTE Study Group. Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial. JAMA Surg. 2024 Feb 1;159(2):129-138. doi: 10.1001/jamasurg.2023.6479.

    PMID: 38117527DERIVED

  • Wang ML, Min J, Sands LP, Leung JM; the Perioperative Medicine Research Group. Midazolam Premedication Immediately Before Surgery Is Not Associated With Early Postoperative Delirium. Anesth Analg. 2021 Sep 1;133(3):765-771. doi: 10.1213/ANE.0000000000005482.

    PMID: 33721875DERIVED

  • Kowark A, Rossaint R, Keszei AP, Bischoff P, Czaplik M, Drexler B, Kienbaum P, Kretzschmar M, Rex C, Saller T, Schneider G, Soehle M, Coburn M; I-PROMOTE study group. Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial. Trials. 2019 Jul 15;20(1):430. doi: 10.1186/s13063-019-3512-3.

    PMID: 31307505DERIVED

MeSH Terms

Conditions

Anxiety DisordersPatient Satisfaction

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark Coburn, Professor

    Department of Anesthesiology, University Hospital Aachen, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 14, 2017

Study Start

October 12, 2017

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(9)