Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT04540666
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VR Sedation in Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative propofol dose', 'timeFrame': 'From the start of anaesthesia to the end of anaesthesia, up to 2 hours after the start of surgery', 'description': 'Amount of propofol required during surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anaesthesia for dental surgery', 'Sedation for dental surgery'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Anaesthesia or sedation for dental surgery is Challenging. Over-sedation, leading to upper airway obstruction, desaturation and apnoea, is very common. On the other hand, it is also very common that inadequate sedative drugs were given, leading to under-sedation with unsatisfactory experience during operation. Therefore, it is good if some other methods are provided for sedation, avoiding side effects associated with sedative drugs.', 'detailedDescription': 'Immersive virtual reality (VR) is a form of distraction therapy and is believed to create an immersive experience that can restrict the mind from pain and anxiety and has been shown to be superior to simple distraction in reducing pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral impacted lower third molar that requires surgical removal\n* Depth of impaction within 8mm as measured by Winter's line.\n* Cantonese speaking\n\nExclusion Criteria:\n\n* ASA \\> III\n* BMI \\> 35\n* Known Obstructive Sleep Apnoea\n* Patients with known or potential difficult airway\n* Chronic use of sedatives and opioid\n* Alcohol or drug abuse\n* Visual and hearing impairments\n* Claustrophobia\n* Cognitive impairment\n* History of seizure"}, 'identificationModule': {'nctId': 'NCT04540666', 'briefTitle': 'VR Sedation in Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Sedation Sparing Effect of Virtual Reality in Third Molar Surgery', 'orgStudyIdInfo': {'id': 'UW20-453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR group', 'description': 'VR program will be displayed throughout the surgery.', 'interventionNames': ['Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-VR group', 'description': 'VR program will be turned off throughout the surgery.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.', 'armGroupLabels': ['Non-VR group', 'VR group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Doctor, Consultant of Department of Anaesthesiology, Queen Mary Hospital; Principal Investigator, Honorary Clinical Associate Professor, Department of Anaesthesiology, The University of Hong Kong', 'investigatorFullName': 'Dr. Chan Chi-Wing', 'investigatorAffiliation': 'The University of Hong Kong'}}}}