Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-12 @ 12:47 AM
Study NCT ID:
NCT02213302
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2014-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premedication by Midazolam for Emergency Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, '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': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale of anxiety', 'timeFrame': 'baseline, up to the end of support in recovery room', 'description': 'visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period'}], 'secondaryOutcomes': [{'measure': 'salivary cortisol level', 'timeFrame': 'baseline and at the entrance in operating room', 'description': 'biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)'}, {'measure': 'Global anxiety', 'timeFrame': 'baseline', 'description': 'rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men'}, {'measure': "Patient's satisfaction", 'timeFrame': 'at the end of the support in recovery room', 'description': 'rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room'}, {'measure': 'Intraoperative consumption of hypnotics and opioids', 'timeFrame': 'at anesthesia induction up to 10 minutes', 'description': 'Cumulative dose of hypnotics and opioids reduced to dose per kilogram'}, {'measure': 'Comfort induction', 'timeFrame': 'at anesthesia induction', 'description': 'rated from 1 for deep discomfort to 5 for good comfort'}, {'measure': 'Intubation score', 'timeFrame': 'after intubation', 'description': 'Rated from 1 bed conditions for intubation to 5 for excellent conditions'}, {'measure': 'Adverse midazolam effects', 'timeFrame': 'baseline up to the end of support in recovery room', 'description': "assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient"}, {'measure': 'Output score of recovery room (Aldrete score)', 'timeFrame': 'at the end of support in recovery room', 'description': 'rated from 0 to 10 essential for the output of recovery room'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['premedication', 'preoperative anxiety', 'salivary cortisol level', 'anxiety visual analog scale'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '18772216', 'type': 'RESULT', 'citation': 'Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.'}, {'pmid': '2457102', 'type': 'RESULT', 'citation': 'Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.'}, {'pmid': '15217656', 'type': 'RESULT', 'citation': "Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83. doi: 10.1016/j.jclinane.2003.07.003."}, {'pmid': '16243241', 'type': 'RESULT', 'citation': 'Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.'}, {'pmid': '21602018', 'type': 'RESULT', 'citation': 'Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.'}, {'pmid': '8623940', 'type': 'RESULT', 'citation': 'Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.'}, {'pmid': '3156545', 'type': 'RESULT', 'citation': 'Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.'}, {'pmid': '20224951', 'type': 'RESULT', 'citation': 'Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.'}]}, 'descriptionModule': {'briefSummary': 'Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major patient undergoing elective surgery under general anesthesia with tracheal intubation\n* Anesthesia state 1 and 2\n* preoperative fasting for 6 hours\n* information and signed consent\n* social security\n* non pregnant women\n\nExclusion Criteria:\n\n* anesthesia state above 3\n* midazolam sensibility\n* pregnant or breastfeeding women\n* ICU patients\n* no consent\n* pediatric surgery\n* no social security\n* no tracheal intubation\n* required premedication in placebo group or midazolam sensibility in premedication group'}, 'identificationModule': {'nctId': 'NCT02213302', 'briefTitle': 'Premedication by Midazolam for Emergency Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery', 'orgStudyIdInfo': {'id': '2014-000873-38'}, 'secondaryIdInfos': [{'id': 'PROM 2012_30', 'type': 'OTHER', 'domain': 'University hospital, Lille'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic serum', 'description': 'placebo administration', 'interventionNames': ['Drug: placebo administration', 'Drug: midazolam intravenous administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'midazolam intravenous administration 0.02mg/kg', 'interventionNames': ['Drug: placebo administration', 'Drug: midazolam intravenous administration']}], 'interventions': [{'name': 'placebo administration', 'type': 'DRUG', 'otherNames': ['isotonic saline serum intravenous administration'], 'armGroupLabels': ['Isotonic serum', 'Midazolam']}, {'name': 'midazolam intravenous administration', 'type': 'DRUG', 'otherNames': ['hypnovel'], 'armGroupLabels': ['Isotonic serum', 'Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Emergency, University Hopital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Elise Blondé-Zoonekynd, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}