Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT03420560
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2018-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Warmer Temperature Decrease Propofol Injection Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072736', 'term': 'Propofol Infusion Syndrome'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will not knowing the exact temperature of the room,thought they will have their own feeling about it. Data was collecting with a anesthesia nurse who do not know what will do with these data. data were assessed to an anesthesiologist who did not know the Group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients for observation will sent to a warmer operating room,while Patients in controled Group will send to normal setting operating room at about 23 centigrade.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intensity of injection pain', 'timeFrame': '3 months', 'description': 'intensity of injection pain was reported by patient themselves before loss their awareness.'}, {'measure': 'numbers of lidocaine rescues for severe injection pain', 'timeFrame': '3 months', 'description': 'when unbearable injection happens,patient could ask for stop and 20mg lidocaine was injected as rescue treatments.'}, {'measure': 'incidences of injection pain', 'timeFrame': '3 months', 'description': 'Numeric Visual Analog Scale of injection \\>2 was counted as injection pain happens,the total incidence of injection was compared in two groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Injection Site Irritation', 'Propofol Syndrome', 'Temperature Change, Body']}, 'descriptionModule': {'briefSummary': 'Propofol injection pain will be surfed by up to 70-80 percentage by the Patients who induced by propofol. Temperature of Operating room was set to a certain range in normal clinical practice, which is 22- 26 centigrade. Warm feeling will make skin vassal dilated and more blood will pass through to bring more heat out of our body. It had been reported that a bigger venous vessels will get less propofol injection pain.\n\nThe investigators hypothesis that Patients who stayed in a warmer room temperature will surf less injection pain while compare to a normal setting room temperature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I\\~III, aged 18，scheduled or emergency surgery with general anesthesia.\n\nExclusion Criteria:\n\n* a history of allergy to propofol, allergy to soybean oil\n* with peripheral blood diseases.'}, 'identificationModule': {'nctId': 'NCT03420560', 'briefTitle': 'A Warmer Temperature Decrease Propofol Injection Pain', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Chenzhou"}, 'officialTitle': 'A Warmer Room-temperature at 27-28 Centi-degree Will Decrease Propofol Injection Pain', 'orgStudyIdInfo': {'id': 'Warm Decrease Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'warmer temperature', 'description': 'To compare the incidence and intensity of pain on injection that is caused by propofol in warm temperature（27℃） versus normal temperature(23℃).', 'interventionNames': ['Behavioral: warmer temperature']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal temperature', 'description': 'The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol in different room temperature(27 VS 23).', 'interventionNames': ['Behavioral: warmer temperature']}], 'interventions': [{'name': 'warmer temperature', 'type': 'BEHAVIORAL', 'description': 'Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.', 'armGroupLabels': ['normal temperature', 'warmer temperature']}]}, 'contactsLocationsModule': {'locations': [{'zip': '423000', 'city': 'Chenzhou', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiming Zhang, MD.Ph.D', 'role': 'CONTACT', 'email': 'otc0735@163.com', 'phone': '+8613875555649'}], 'facility': "Chenzhou No.1 People's hopital", 'geoPoint': {'lat': 25.8, 'lon': 113.03333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xingui Dai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xingui Dai', 'investigatorAffiliation': "First People's Hospital of Chenzhou"}}}}