Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03194594
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2017-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone and Ketamine on Change of Postoperative Mood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-18', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-18', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of patient health questionnaire (PHQ)-9 scores', 'timeFrame': 'at the 1st day after surgery', 'description': 'Anesthesiologist performed the assessment of perioperative depressed mood change with use of Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) with a total score ranging from 0 to 27; 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depressed mood'}], 'secondaryOutcomes': [{'measure': 'postoperative visual analog scale (VAS) for pain', 'timeFrame': 'for 48 h after surgery', 'description': 'The VAS consisted of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients were asked to mark the position on the line corresponding to their perception of pain. The VAS score for pain was measured with intervals of 1, 6, 24, and 48 hours after surgery.'}, {'measure': 'patient controlled analgesia (PCA) consumption', 'timeFrame': 'for 24 h after surgery', 'description': 'Each patient was administered analgesics using a PCA pump containing morphine (60 mg), ketorolac (150 mg), and ramosetron (0.6 mg) in a total volume of 100 ml of saline. This device was set to deliver a basal infusion of 2 ml/hr and bolus doses of 0.5 ml with a 15 min lockout period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine, dexamethasone, mood'], 'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies also have reported these two drugs might change mood such as depression. This study aimed to investigate the effect of each drug individually with their combination on perioperative change of mood in patients undergoing gynecologic surgery', 'detailedDescription': 'After receiving by IRB approval and obtaining informed consent from patients, 93 patients who are aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II.\n\nAfterward, the patients will be randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receive dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'A total of 93 patients\n\nInclusion Criteria:\n\n* patients who were scheduled for laparoscopic gynecologic surgery\n\nExclusion Criteria:\n\n* Patients with hepatic and renal insufficiency, history of allergy to the study drugs, previous gastric ulcer, diabetes mellitus, and receiving analgesic, antiemetic, antihistamine, steroids or psychiatric drugs within 24 hours before surgery steroids'}, 'identificationModule': {'nctId': 'NCT03194594', 'briefTitle': 'Dexamethasone and Ketamine on Change of Postoperative Mood', 'organization': {'class': 'OTHER', 'fullName': 'Wonkwang University Hospital'}, 'officialTitle': 'The Effects of Combination of Intravenous Dexamethasone and Ketamine on Change of Postoperative Mood in Patients Undergoing Laparoscopically Assisted Gynecologic Surgery.', 'orgStudyIdInfo': {'id': 'WonkwangUH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group K (n = 31)', 'description': 'will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia', 'interventionNames': ['Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D (n = 31)', 'description': 'will receive dexamethasone 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia', 'interventionNames': ['Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs']}, {'type': 'EXPERIMENTAL', 'label': 'Group KD (n = 31)', 'description': 'will receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v., at 5 minutes after the induction of anesthesia', 'interventionNames': ['Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs']}], 'interventions': [{'name': 'Ketamine Hydrochloride, dexamethasone, and combination of two drugs', 'type': 'DRUG', 'description': 'After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.', 'armGroupLabels': ['Group D (n = 31)', 'Group K (n = 31)', 'Group KD (n = 31)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '570-711', 'city': 'Iksan', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'WonwangUH', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}], 'overallOfficials': [{'name': 'Cheol Lee, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang UH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonkwang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief professor, principal investigator', 'investigatorFullName': 'Cheol Lee', 'investigatorAffiliation': 'Wonkwang University Hospital'}}}}