Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT05155969
Status:
UNKNOWN
Last Update Posted:
2021-12-14
First Post:
2021-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Postoperative 5 Days', 'description': '≥50% reduction in MADRS scores from the baseline value. The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression'}], 'secondaryOutcomes': [{'measure': 'Anxiety symptom', 'timeFrame': 'Postoperative 5 days', 'description': 'The anxious symptom is defined as a GAD-7 score no less than 10. The GAD-7 is a 7-item tool, with scores ranging from 0 to 21, The higher the score, the worse the anxiety.'}, {'measure': 'Postoperative delirium', 'timeFrame': '1-7days after surgery, on the 30th day after surgery', 'description': 'Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)'}, {'measure': 'Postoperative insomnia', 'timeFrame': 'Postoperative 5 days', 'description': 'Postoperative insomnia is defined as an ISI score of no less than 15. ISI is a 7-item tool, with scores ranging from 0 to 28, The higher the score, the worse insomnia.'}, {'measure': 'Severe pain', 'timeFrame': 'Postoperative 3 days.', 'description': 'The incidence of severe pain within first postoperative three days, which is defined as mean and peak numerical rating scale (NRS) are higher than 5.'}, {'measure': 'Postoperative 30-day quality of life reported by SF-36', 'timeFrame': 'postoperative 30 days', 'description': 'The quality of life will be evaluated by the 36-Item Short-Form Health Survey, SF-36 at postoperative 30 days SF-36 is a 36-item tool, with scores ranging from 1 to 100, The higher the score, the better the quality of life.'}, {'measure': 'Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Postoperative 5 days', 'description': 'Postoperative complications'}, {'measure': 'Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)', 'timeFrame': 'Postoperative 5 days'}, {'measure': 'Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).', 'timeFrame': 'Postoperative 5 days'}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative 2 days', 'description': 'The postoperative pain will be evaluated by Numerical pain scale（NRS） NRS is a tool with scores ranging from 1 to 10, the higher the score, the more intense the pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esketamine', 'postoperative depression', 'cardic surgey'], 'conditions': ['Postoperative Depression']}, 'descriptionModule': {'briefSummary': 'Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.', 'detailedDescription': 'Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression.\n\nIn patients undergoing cardiac surgery, postoperative depressive symptoms are common.\n\nThis study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1:Patients scheduled for heart surgery\n* 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors\n* 3:Over 18 years of age\n* 4:American Society of Anesthesiologists physical status I-III\n\nExclusion Criteria:\n\n* 1:History of epilepsy\n* 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks\n* 3: Psychiatric illness\n* 4: Drug abuse\n* 5:History of allergy to esketamine\n* 6:Hyperthyroidism\n* 7:Patients can not cooperate with investigators on psychiatric assessments\n* 8:Pregnant or breastfeeding woman\n* 9:refuse to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT05155969', 'briefTitle': 'Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Evaluating the Effect of Subanaesthetic Dose of Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery：a Randomized, Double-blind, Placebo-controlled Pilot and Feasibility Trial', 'orgStudyIdInfo': {'id': '10110815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eskatamine group', 'description': 'Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction', 'interventionNames': ['Drug: Esketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['Ketamine hydrochloride'], 'description': 'esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction', 'armGroupLabels': ['Eskatamine group']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'Normal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anshi Wu, MD', 'role': 'CONTACT', 'email': 'wuanshi1965@163.com', 'phone': '+8685231330'}, {'name': 'Anshi Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anshi Wu, Ph.D', 'role': 'CONTACT', 'email': 'wuanshi1965@163.com', 'phone': '+861085351330', 'phoneExt': 'Wu anshi'}], 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Anshi Wu Wu, Ph.D', 'role': 'CONTACT', 'email': 'wuanshi1965@163.com', 'phone': '+861085351330', 'phoneExt': 'Wu'}], 'overallOfficials': [{'name': 'Anshi Wu Wu, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Chao-Yang Hospital, Capital Medical Unive'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anshi Wu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology', 'investigatorFullName': 'Anshi Wu', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}