Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT04613869
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Esketamine on Patients Undergoing Tumor Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 282}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-01', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-01', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of moderate to severe pain', 'timeFrame': 'Within 72 hours after surgery', 'description': 'Visual analog score is 4 points or more'}, {'measure': 'Pain score', 'timeFrame': 'Within 72 hours after surgery', 'description': 'Visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': 'Within 72 hours after surgery', 'description': 'Nausea, vomiting, lethargy, mental symptoms, etc.'}, {'measure': 'Postoperative analgesia', 'timeFrame': 'Within 48 hours after surgery', 'description': 'PCIA usage（ml）, PCIA compressions（frequency）, remedial analgesia measures（Name and dosage of intravenous analgesics）'}, {'measure': 'Sedation', 'timeFrame': 'Within 48 hours after surgery', 'description': 'Ramsay sedation score（The score is 1-6 points, the higher the score, the higher the degree of sedation, the ideal sedation score is 2 points）'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline (Before operation), 24 hours after operation, 72 hours after operation', 'description': 'Hamilton Anxiety Scale（There are a total of 14 options. Each item is divided into 0-4 points according to the degree, and the score is 0-56 points. The total score is ≥29 points, which may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, there must be Anxiety; more than 7 points, there may be anxiety; if less than 7, there are no anxiety symptoms.）'}, {'measure': 'Depression', 'timeFrame': 'Baseline (Before operation), 24 hours after operation, 72 hours after operation', 'description': 'Hamilton Depression Scale（There are a total of 17 options, and each item is divided into 0-4 points or 0-2 points according to the degree. The total score is less than 7 points: normal; the total score is 7\\~17 points: there may be depression; the total score is 17\\~24 points : There must be depression; total score\\> 24 points: severe depression）'}, {'measure': 'Sleep condition', 'timeFrame': 'Within 72 hours after surgery', 'description': 'Sleep quality（Self-assessment by the patient, the score is 1-5 points, the higher the score, the better the sleep）'}, {'measure': 'Chronic pain', 'timeFrame': 'One month after surgery', 'description': 'Chronic pain conversion rate（Follow-up one month after surgery, if there are still pain symptoms, it is chronic pain）'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor Surgery']}, 'descriptionModule': {'briefSummary': 'Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，The new analgesic anesthetic esketamine hydrochloride was launched in China last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old;\n* Patients undergoing elective tumor surgery\n* Use intravenous analgesia pump (PCIA) after operation\n\nExclusion Criteria:\n\n* Patients with severe infection or respiratory system diseases;\n* Severe arrhythmia, unstable angina or myocardial infarction, heart failure;\n* Patients with severe diseases of liver, kidney, endocrine or immune system; ·Patients with fever before operation;\n* One month before operation Patients receiving chemotherapy, radiotherapy or immunotherapy;\n* Drug or alcohol dependence;\n* Mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete;\n* Long-term use of antidepressant and anxiety drugs;\n* High intracranial pressure High intraocular pressure'}, 'identificationModule': {'nctId': 'NCT04613869', 'briefTitle': 'The Effect of Esketamine on Patients Undergoing Tumor Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery', 'orgStudyIdInfo': {'id': '2020-818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose esketamine group', 'description': 'After the operation, 5 mg esketamine was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 45mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/kg , Background dose 2ug/kg/h, single dose 4ug/kg/time', 'interventionNames': ['Drug: High-dose Esketamine hydrochloride+Hydromorphone']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose esketamine group', 'description': 'After the operation, esketamine 2.5mg was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 22.5mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/ kg, background dose 2ug/kg/h, single dose 4ug/kg/time', 'interventionNames': ['Drug: Low-dose Esketamine hydrochloride+Hydromorphone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'PCIA formula: 6mg of hydromorphone + 10mg of tropisetron into 100ml of 0.9% sodium chloride injection, the first dose is 20ug/kg, the background dose is 2ug/kg/h, and the single dose is 4ug/kg/time.', 'interventionNames': ['Drug: Hydromorphone']}], 'interventions': [{'name': 'High-dose Esketamine hydrochloride+Hydromorphone', 'type': 'DRUG', 'description': 'By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients', 'armGroupLabels': ['High-dose esketamine group']}, {'name': 'Low-dose Esketamine hydrochloride+Hydromorphone', 'type': 'DRUG', 'description': 'By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients', 'armGroupLabels': ['Low-dose esketamine group']}, {'name': 'Hydromorphone', 'type': 'DRUG', 'description': 'No esketamine added', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University anesthesiology department', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Min Yan, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}