Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 2:02 PM
Study NCT ID:
NCT01126957
Status:
TERMINATED
Last Update Posted:
2023-04-24
First Post:
2010-05-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Ketamine/Propofol for Emergency Department Procedural Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], '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': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'henryda@missouri.edu', 'phone': '573/884-2582', 'title': 'Dr. David Henry', 'organization': 'University of Missouri-Columbia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '107 participants were consented for the study. 4 were terminated by the investigator as they received surgery and were no longer eligible.\n\nNo data were analyzed/available as the target number of 200 was not reached; the PI has left the institution.'}}, 'adverseEventsModule': {'timeFrame': 'For the duration of the procedure for which each participant required sedation.', 'description': 'Adverse event data were not made available by the investigator prior to him leaving the institution.', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine or Placebo', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or palcebo, followed by propofol to maintain sedation.\n\nKetamine: Ketamine was given as a 0.5mg / Kg bolus.\n\nFentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo\n\nPropofol: Propofol given to both arms to maintain sedation throughout procedure.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Respiratory Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine or Placebo', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.\n\nKetamine: Ketamine was given as a 0.5mg / Kg bolus.\n\nFentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo\n\nPropofol: Propofol given to both arms to maintain sedation throughout procedure.'}], 'timeFrame': 'Baseline and throughout procedure', 'description': '1. Endotracheal carbon dioxide (ETCO2) rise \\> 5mm/hg\n2. Arterial oxygen saturation (SaO2) \\<90%\n3. Respiratory rate (RR) \\< 8 br/min\n4. Apnea \\> 15 sec\n5. airway manipulation', 'reportingStatus': 'POSTED', 'populationDescription': '103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Procedural Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.\n\nKetamine: Ketamine was given as a 0.5mg / Kg bolus.\n\nFentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo\n\nPropofol: Propofol given to both arms to maintain sedation throughout procedure.'}], 'timeFrame': '20 minutes', 'description': 'Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation', 'reportingStatus': 'POSTED', 'populationDescription': '103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine or Placebo', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation.\n\nKetamine: Ketamine was given as a 0.5mg / Kg bolus.\n\nFentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo\n\nPropofol: Propofol given to both arms to maintain sedation throughout procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '107 participants were consented for the study. 103 completed.', 'preAssignmentDetails': 'We know that 107 participants had enrolled as of February 2008 and that 4 were terminated by the PI as not eligible. 103 were noted to have completed. However, the PI left the institution without making available any results or analyzed data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine or Placebo', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.\n\nKetamine: Ketamine was given as a 0.5mg / Kg bolus.\n\nFentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo\n\nPropofol: Propofol given to both arms to maintain sedation throughout procedure.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age >1 year', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male and Female', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '107 participants signed the consent but 4 were found ineligible. 103 participants started and completed the study. Data were collected but not analyzed as the investigator left the institution prior to analysis and did not make data available for others to analyze.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'whyStopped': 'Investigator left institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2010-05-11', 'resultsFirstSubmitDate': '2016-09-23', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-19', 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Depression', 'timeFrame': 'Baseline and throughout procedure', 'description': '1. Endotracheal carbon dioxide (ETCO2) rise \\> 5mm/hg\n2. Arterial oxygen saturation (SaO2) \\<90%\n3. Respiratory rate (RR) \\< 8 br/min\n4. Apnea \\> 15 sec\n5. airway manipulation'}], 'secondaryOutcomes': [{'measure': 'Satisfaction With Procedural Sedation', 'timeFrame': '20 minutes', 'description': 'Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Procedural Sedation and Analgesia']}, 'descriptionModule': {'briefSummary': "Introduction\n\nNumerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. The investigators designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. The investigators hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone.\n\nMethods\n\nStudy design\n\nThe investigators conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.", 'detailedDescription': "Introduction\n\nNumerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. We designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. Our hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone.\n\nMethods\n\nStudy design\n\nWe conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From May 2007 until March 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.\n\nStudy setting and population\n\nAll patients requiring PSA in the ED were viewed as potential subjects unless they were pregnant, less than 1 year of age, history of prior adverse reaction to anesthesia, underlying cardiac or pulmonary disease, hepatic dysfunction, porphyria, psychiatric illness, allergy to eggs/soybeans, increased intracranial or intraocular pressure, abnormal airway pathology or an American Society of Anesthesiologists (ASA) score of 3 or greater. The attending ED physician would then approach the patient to enroll them in the study. If the patient accepted they were randomized by the hospital pharmacy.\n\nStudy protocol\n\nAn ED attending physician was dedicated to PSA throughout the procedure. Patients had EKG, blood pressure, respiratory rate, pulse oximetry, and end-tidal carbon dioxide (PetCO2) monitored, had IV access obtained and were placed on nasal cannula oxygen supplementation. All patients received pre-procedure analgesia with 0.5 to 1.5 mcg/Kg of fentanyl and all patients had reflective sunglasses placed so as to obscure eye movements from the staff.\n\nSubjects were randomized by the pharmacy in blocks of ten. Consecutively numbered pre-filled 3cc syringes were prepared by the pharmacy staff once they received a signed and dated study enrollment sheet from the ER staff with the patients weight in kilograms provided. All physicians, nurses, patients and study personnel were blinded to the contents of the syringes which were hand delivered by pharmacy personnel.\n\nPatients were randomized to receive either 0.5 mg/Kg of ketamine or placebo (normal saline) delivered to the emergency room sedating physician in a 3 cc syringe containing a clear/colorless solution. This solution was delivered intravenously over a one minute infusion. On completion of this infusion all patients received propofol starting at 1 mg/Kg over 2 minutes and supplemented with repeated boluses of 0.5 mg/Kg to maintain adequate sedation. Patients were felt to be adequately sedated once they received a Colorado Behavioral Numerical Pain Scale (CBNPS) score of 0 to 113(table 1.) Patients were monitored after the procedure until a normal level of consciousness was observed.\n\nThe quantity of all drugs delivered were recorded. During the procedure all patients were monitored for 5 respiratory depression markers:\n\n* PetCO2 rise of ³ 5 mm/Hg\n* Respiratory rate \\< 8 br/min\n* arterial oxygen saturation (SaO2) \\< 90%\n* Apnea ³ 15 seconds\n* Airway manipulation\n\nPhysicians were permitted to intervene and provide any supportive/resuscitative measures at there discretion despite the pre-specified respiratory depression markers.\n\nAll data were collected and recorded on standardized Hospital PSA forms. Data was collected for the entire time frame of the individual procedural sedations. Following the completion of the procedural sedation a second form was filled out by both the sedating physician and monitoring nurse recording specifically any respiratory events/rescue interventions and overall satisfaction with the procedural sedation. The overall quality of the PSA was evaluated by the physician/nurse performing the sedation as one of the following:\n\n1. Not satisfied\n2. Somewhat satisfied\n3. Satisfied\n4. Very satisfied\n5. Excellent\n\nAll data was recorded on a secure computer in spreadsheet form (Microsoft Excel 2003, Microsoft Corporation, Redmond, WA) for later analysis.\n\nOutcome Measures\n\nFour endpoints were defined prior to study initiation:\n\nRespiratory Depression. A difference in evidence of respiratory depression between the groups. Respiratory depression was defined as the occurrence of any of the 5 markers.\n\nSatisfaction with PSA. A difference in the evaluation of the quality of the sedation by the providers.\n\nQuality of PSA. Number of patients with a CBNPS of 0.\n\nPropofol usage. Did the addition of ketamine significantly reduce the amount of propofol needed to produce adequate PSA.\n\nData analysis We plan to enroll 100 patients in each group. This is based on an estimate of a 40% incidence of respiratory depression with propofol alone, a reduction to 20% with the combination of ketamine/propofol, an a of 0.05 and a power of 0.8.14-16. An interim analysis was conducted at enrollment of 100 patients using a significance of 0.025 for difference in respiratory depression.\n\nRespiratory depression and CBNPS were compared using a chi-squared test and Satisfaction with PSA and Quality of PSA were compared using a t-test. Tests were done with Primer of Biostatistics (Version 6.0, Stanton A. Glantz, 2005)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals from 1 year of age and up without the below exclusion criteria\n\nExclusion Criteria:\n\n* Subjects: All patients who require ED conscious sedation and do not meet any of the following exclusion criteria are eligible for study participation:\n\n * Age \\< 1yr\n * History of prior adverse reaction to anesthesia\n * History of cardiac disease\n * History of pulmonary disease\n * Hepatic dysfunction\n * Thyroid disease\n * Pregnancy\n * Porphyria\n * Psychiatric Illness\n * Allergy to eggs, soybeans, or sulfites\n * Increased intracranial or intraocular pressure\n * Active upper respiratory infection in children\n * Abnormal airway\n * ASA score of III or greater'}, 'identificationModule': {'nctId': 'NCT01126957', 'briefTitle': 'Combined Ketamine/Propofol for Emergency Department Procedural Sedation', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Combined Ketamine/Propofol for Emergency Department Procedural Sedation', 'orgStudyIdInfo': {'id': 'Project Number: 1084480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation.', 'interventionNames': ['Drug: Ketamine', 'Drug: Fentanyl', 'Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.', 'interventionNames': ['Drug: Placebo', 'Drug: Fentanyl', 'Drug: Propofol']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'Ketamine was given as a 0.5mg / Kg bolus.', 'armGroupLabels': ['Ketamine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given as an bolus to control group.', 'armGroupLabels': ['Placebo']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Sublimaze'], 'description': 'Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo', 'armGroupLabels': ['Ketamine', 'Placebo']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Propofol given to both arms to maintain sedation throughout procedure.', 'armGroupLabels': ['Ketamine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri - Columbia dept. of Emergency Medicine', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Henry David, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}