Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT01866605
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'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': '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale score for anxiety', 'timeFrame': 'During immediate pre-operative phase'}], 'secondaryOutcomes': [{'measure': 'Thermal comfort', 'timeFrame': 'During immediate pre-operative phase'}, {'measure': 'Recovery from anaesthesia', 'timeFrame': 'During immediate post-operative phase'}, {'measure': 'Satisfaction with care', 'timeFrame': 'During immediate post-operative phase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety', 'midazolam', 'forced-air warming'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'Patients are often anxious immediately before surgery. The investigators hypothesis is that a warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.', 'detailedDescription': 'The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* male and female\n* presenting for elective surgery\n* requiring general anaesthesia\n* ASA 1-3\n\nExclusion Criteria:\n\n* Cardiothoracic and intracranial surgery\n* Day case surgery\n* Pre-existing anxiety disorder\n* Patients on psychotropic drugs preoperatively Febrile patients T \\> 37.5 degrees Celsius Allergy to midazolam Obstructive Sleep Apnoea diagnosed on sleep study'}, 'identificationModule': {'nctId': 'NCT01866605', 'briefTitle': 'A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'officialTitle': 'A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients', 'orgStudyIdInfo': {'id': 'HREC 2008.074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room', 'interventionNames': ['Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room', 'interventionNames': ['Device: Bair Hugger']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'Intravenous midazolam 0.3 mg/kg', 'armGroupLabels': ['2']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal saline injection will be given to groups not receiving midazolam', 'armGroupLabels': ['1']}, {'name': 'Bair Hugger', 'type': 'DEVICE', 'description': 'Forced air warming', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'Kate Leslie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}