Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT01993459
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2013-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Midazolam on the Quality of Postoperative Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Recovery (QoR-40 Scale)', 'timeFrame': 'baseline, workday 3 postoperative, workday 7 postoperative'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'baseline, workday 1 postoperative, workday 7 postoperative'}, {'measure': 'Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'baseline, workday 1 postoperative, workday 7 postoperative'}, {'measure': 'Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)', 'timeFrame': 'baseline, workday 7 postoperative'}, {'measure': 'Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).', 'timeFrame': 'baseline, workday 7 postoperative'}, {'measure': 'Change in Systolic bloodpressure', 'timeFrame': 'baseline, workday 1 postoperative'}, {'measure': 'Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)', 'timeFrame': 'baseline, workday 7 postoperative'}, {'measure': 'Change in Diastolic Blood pressure', 'timeFrame': 'baseline, workday 1 postoperative'}, {'measure': 'Temperature after surgery measured with an ear thermometer', 'timeFrame': 'directly after surgery'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'preoperatively, during surgery and postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality of Recovery'], 'conditions': ['Postoperative Period', 'Anxiety', 'Fatigue', 'Depression', 'Aggression']}, 'referencesModule': {'references': [{'pmid': '31576513', 'type': 'DERIVED', 'citation': 'van Beek S, Kroon J, Rijs K, Mijderwijk HJ, Klimek M, Stolker RJ. The effect of midazolam as premedication on the quality of postoperative recovery after laparotomy: a randomized clinical trial. Can J Anaesth. 2020 Jan;67(1):32-41. doi: 10.1007/s12630-019-01494-6. Epub 2019 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days\n\nExclusion Criteria:\n\n* Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients'}, 'identificationModule': {'nctId': 'NCT01993459', 'acronym': 'WOLII', 'briefTitle': 'The Effects of Midazolam on the Quality of Postoperative Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients', 'orgStudyIdInfo': {'id': '14091991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midazolam intravenous', 'description': '3mg/ml midazolam given intravenously', 'interventionNames': ['Drug: Midazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl (sodium chloride) 0,9%', 'description': 'NaCl (sodium chloride) 0,9% given intravenously 3ml.', 'interventionNames': ['Drug: NaCl (sodium chloride) 0,9%']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery', 'armGroupLabels': ['Midazolam intravenous']}, {'name': 'NaCl (sodium chloride) 0,9%', 'type': 'DRUG', 'otherNames': ['saline solution', 'sodium chloride solution'], 'description': 'We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery', 'armGroupLabels': ['NaCl (sodium chloride) 0,9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000CA', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Robert Jan Stolker, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Erasmus MC Rotterdam Anesthesiology'}, {'name': 'Markus Klimek, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Erasmus MC Rotterdam Anesthesiology'}, {'name': 'Stefan van Beek, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus MC Rotterdam Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSc', 'investigatorFullName': 'Stefan van Beek', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}