Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-01 @ 11:40 AM
Study NCT ID:
NCT01365195
Status:
TERMINATED
Last Update Posted:
2022-03-02
First Post:
2011-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Ketamine on Postoperative Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ofelia.Elvir-Lazo@cshs.org', 'phone': '310-423-1682', 'title': 'Research project Advisor', 'organization': 'Cedars Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one month', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate'}, {'id': 'OG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min'}, {'id': 'OG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate'}, {'id': 'OG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min'}, {'id': 'OG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '1', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With Nausea and Vomiting at PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate'}, {'id': 'OG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min'}, {'id': 'OG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate'}, {'id': 'FG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min'}, {'id': 'FG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate'}, {'id': 'BG001', 'title': 'Ketamine Low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min'}, {'id': 'BG002', 'title': 'Ketamine High-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '21', 'groupId': 'BG000'}, {'value': '46', 'spread': '24', 'groupId': 'BG001'}, {'value': '58', 'spread': '12', 'groupId': 'BG002'}, {'value': '48', 'spread': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'recruitment failure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2011-06-01', 'resultsFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Opioid Consumption', 'timeFrame': '1 day', 'description': 'Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'one day', 'description': 'Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain.'}, {'measure': 'Participants With Nausea and Vomiting at PACU', 'timeFrame': '1 day', 'description': 'Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid', 'Fentanyl', 'Anesthetic adjuvant', 'Pain management', 'Perioperative outcomes', 'Constipation', 'Ileus', 'Colorectal'], 'conditions': ['Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.', 'detailedDescription': 'Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy\n2. Willingness and ability to sign an informed consent document\n3. No allergies to anesthetic or analgesic medications\n4. 18 - 80 years of age\n5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex\n\nExclusion Criteria\n\n1. Inability to comprehend the pain assessment tools\n2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications\n3. Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of cerebral vascular accident (CVA), or chronic renal insufficiency\n4. Prior abdominal surgery\n5. History of abdominal carcinomatosis\n6. History of radiation enteritis;\n7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes\n8. Patients with seizures\n9. Morbid obesity (body mass index \\>40)\n10. Pregnant or lactating women\n11. Subjects with a history of alcohol or drug abuse within the past 3 months\n12. Any other conditions or use of any medication which may interfere with the conduct of the study\n13. Prophylactic Nasogastric Tube (NGT) use\n14. Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis\n15. Individuals with asthma and/or thyroid diseases'}, 'identificationModule': {'nctId': 'NCT01365195', 'briefTitle': 'Effect of Ketamine on Postoperative Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes', 'orgStudyIdInfo': {'id': 'Pro00024533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Loading and Infusion:\n\nSaline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate', 'interventionNames': ['Drug: Ketamine high-dose', 'Drug: Ketamine low-dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine low-dose', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min', 'interventionNames': ['Drug: Placebo', 'Drug: Ketamine high-dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine high-dose', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min', 'interventionNames': ['Drug: Placebo', 'Drug: Ketamine low-dose']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline Solution'], 'description': 'Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate', 'armGroupLabels': ['Ketamine high-dose', 'Ketamine low-dose']}, {'name': 'Ketamine high-dose', 'type': 'DRUG', 'description': 'Loading: 1 mg/Kg Infusion: 10 mcg/kg/min', 'armGroupLabels': ['Control', 'Ketamine low-dose']}, {'name': 'Ketamine low-dose', 'type': 'DRUG', 'description': 'Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min', 'armGroupLabels': ['Control', 'Ketamine high-dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Roya Yumul, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Roya Yumul, MD., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Residency program director, Department of anesthesiology', 'investigatorFullName': 'Roya Yumul, M.D.,PhD.', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}