Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-04-21 @ 8:32 PM
Study NCT ID:
NCT03052660
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2017-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Preoperative Midazolam on Outcome of Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 782}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global patient satisfaction on the first postoperative day', 'timeFrame': 'on the first postoperative day (1 day)', 'description': 'measured with the EVAN-G questionnaire on the first postoperative day'}], 'secondaryOutcomes': [{'measure': 'Cognitive testing', 'timeFrame': 'preoperative, day 1 and day 30 after surgery (31 days)', 'description': 'Measured by the short blessed test'}, {'measure': 'Delirium testing', 'timeFrame': 'preoperative, day 1 after surgery (2 days)', 'description': 'Measured by Confusion Assessment Method (CAM)'}, {'measure': 'Preoperative anxiety', 'timeFrame': 'preoperatively (1 day)', 'description': 'Measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS)'}, {'measure': 'Change of health-related quality of life', 'timeFrame': 'preoperative and day 30 after surgery (31 days)', 'description': 'Measured by the individual health-related quality of life assessment EQ-5D-5L'}, {'measure': 'Activities of daily living', 'timeFrame': 'preoperative and day 30 after surgery (31 days)', 'description': 'Measured by Instrumental Activities of Daily Living scale (IADL)'}, {'measure': 'Perception of pain, well-being, and sleeping', 'timeFrame': 'preoperative until first postoperative day (3 days)', 'description': 'Self-reported by visual analogue scale (VAS)'}, {'measure': 'Number of participants with adverse events and serious adverse events', 'timeFrame': 'surgery and first postoperative day (2 days)', 'description': 'Review of medical charts and patient interview'}, {'measure': 'Patient cooperation', 'timeFrame': 'surgery day (1 day)', 'description': 'Self-reported by visual analogue scale (VAS) by the attending anesthetist'}, {'measure': 'Anaesthesia related data', 'timeFrame': 'surgery day (1 day)', 'description': 'Anesthesia drugs, type of anesthesia, duration, extubation-time'}, {'measure': 'Surgery related data', 'timeFrame': 'surgery day (1 day)', 'description': 'Duration and kind of surgery'}, {'measure': 'Rescue benzodiazepine application', 'timeFrame': 'surgery day (1 day)', 'description': 'assessment of additional requirement of midazolam in the operating area'}, {'measure': 'Patients vital data', 'timeFrame': 'surgery day (1 day)', 'description': 'Measurement of SpO2, RRsys, HR on arrival in the operating room and at the end of surgery'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Patient chart review and telephone interview after discharge'}, {'measure': 'Major adverse events', 'timeFrame': '30 days', 'description': 'Assessment of postoperative major adverse cardiovascular and cerebral events by patient chart review and telephone interview after discharge'}, {'measure': 'Hospital length of stay', 'timeFrame': 'on postoperative day 30 (1 day)', 'description': 'Patient chart review'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': 'on postoperative day 30 (1 day)', 'description': 'Patient chart review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midazolam', 'Anxiety', 'Clinical trial', 'Patient Satisfaction'], 'conditions': ['Preanesthetic Medication']}, 'referencesModule': {'references': [{'pmid': '15915023', 'type': 'RESULT', 'citation': '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': '25495432', 'type': 'RESULT', 'citation': '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': '25734733', 'type': 'RESULT', 'citation': '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': '38117527', 'type': 'DERIVED', 'citation': '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': '33721875', 'type': 'DERIVED', 'citation': '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': '31307505', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nPatients will be randomly assigned to one of the following two study groups. Preoperatively, group 1 will receive midazolam and group 2 will receive placebo.\n\nAnaesthesia will be performed according to the clinical routine.\n\nAll 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.\n\nThe 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.\n\nConsidering a drop-out of 10% and a screening failure of 10%, we decided to include 614 patients in total.\n\nThe hypothesis of the study is that global patient satisfaction after surgery in elderly patients is similar after preoperative placebo application compared to midazolam application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 1\\. Only legally competent patients\n2. Written informed consent prior to study participation\n3. 65-80 years\n4. Elective surgery\n5. Expected surgery duration ≥ 30 minutes\n6. Planned general or combined regional and general anaesthesia\n7. Planned extubation at the end of surgery\n\nExclusion Criteria:\n\n1. Age \\> 80 years\n2. Age \\< 65 years\n3. Non-fluency in German language\n4. Alcohol and/ or drugs abuse\n5. Chronic benzodiazepine treatment\n6. Intracranial surgery\n7. Local and stand by anaesthesia or solely regional anaesthesia\n8. Monitored anaesthesia care\n9. Cardiac surgery\n10. Ambulatory surgery\n11. Repeated surgery\n12. Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)\n13. 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).\n14. Expected benzodiazepine requirement after surgery\n15. Expected continuous mandatory ventilation after surgery\n16. Patients who explicitly request anxiolytic premedication\n17. Patients with severe neurological or psychiatric disorders\n18. Refusal of study participation by the patient\n19. Parallel participation in interventional clinical studies within the last 30 days'}, 'identificationModule': {'nctId': 'NCT03052660', 'acronym': 'I-PROMOTE', 'briefTitle': 'Impact of Preoperative Midazolam on Outcome of Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Impact of Preoperative Midazolam on Outcome of Elderly Patients: a Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '16-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midazolam', 'description': 'Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery', 'interventionNames': ['Drug: Midazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, oral, once, 30-45 minutes before surgery', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'Oral administration preoperatively', 'armGroupLabels': ['Midazolam']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Oral administration preoperatively', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Anesthesiology, University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '44625', 'city': 'Herne', 'country': 'Germany', 'facility': 'Marien-Hospital Herne', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg A.ö.R.', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Department of Anaesthesiology, University Hospital Klinikum rechts der Isar Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'LMU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '72764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Kreiskliniken Reutlingen, Klinikum am steinenberg', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Mark Coburn, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, University Hospital Aachen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}