Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-03-10 @ 6:17 PM
Study NCT ID:
NCT03090620
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010830', 'term': 'Physostigmine'}, {'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'george.wang@childrenscolorado.org', 'phone': '303-724-9967', 'title': 'Dr. George Sam Wang', 'organization': 'UColorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We had a smaller sample size. All patients in our cohort ingested antihistamines, the majority of which was diphenhydramine. There were no ingestions of other antimuscarinic xenobiotics. Many of the subjects were enrolled during the overnight hours; in addition to the underlying sedation effect of the ingested agent made an assessment of delirium challenging which may have led to more positive delirium scores in both treatment arms. We did not assess efficacy or safety beyond 4 hours.'}}, 'adverseEventsModule': {'timeFrame': '4 Hours', 'eventGroups': [{'id': 'EG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomitnig', 'notes': 'Vomiting during treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversedation', 'notes': 'Sleepiness, oversedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, immediately before bolus', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately after bolus, up to 10 minutes post-Baseline', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 hours', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, immediately before bolus', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Effectiveness of Physostigmine Infusion in the Setting of Antimuscarinic Toxidrome.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'title': 'Seizures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchorrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchospasm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diaphoresis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intubation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Oversedation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 hours', 'description': 'Evaluation of clinical antimuscarinic symptoms, along with presence of any adverse effects, during the infusion to report tolerability, safety profile, and effectiveness of the infusion. the number of participants exhibiting adverse events will be reported, by type.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately after bolus, up to 10 minutes post-Baseline', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'OG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'FG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.\n\nPhysostigmine: Administration of physostigmine bolus followed by an infusion'}, {'id': 'BG001', 'title': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.\n\nLorazepam: Administration of lorazepam bolus followed by normal saline infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '14.4', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '13.9', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean Heart Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '127', 'spread': '18', 'groupId': 'BG000'}, {'value': '117', 'spread': '10', 'groupId': 'BG001'}, {'value': '122', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '37.2', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Celsius', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Respiratory Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '7', 'groupId': 'BG000'}, {'value': '24', 'spread': '4', 'groupId': 'BG001'}, {'value': '27', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Respirations per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '131', 'spread': '12', 'groupId': 'BG000'}, {'value': '127', 'spread': '14', 'groupId': 'BG001'}, {'value': '129', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Diastolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'spread': '11', 'groupId': 'BG000'}, {'value': '88', 'spread': '17', 'groupId': 'BG001'}, {'value': '84', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nnHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Oxygen Saturations', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '96', 'spread': '2', 'groupId': 'BG000'}, {'value': '97', 'spread': '3', 'groupId': 'BG001'}, {'value': '96', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%Oxygen', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-16', 'size': 458752, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-28T16:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2017-03-10', 'resultsFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-28', 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of RASS Score Between Physostigmine and Lorazepam: Before Bolus', 'timeFrame': 'Baseline, immediately before bolus', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.'}, {'measure': 'Comparison of RASS Score Between Physostigmine and Lorazepam: After Bolus', 'timeFrame': 'Immediately after bolus, up to 10 minutes post-Baseline', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.'}, {'measure': 'Comparison of RASS Score Between Physostigmine and Lorazepam: 4 Hours', 'timeFrame': '4 hours', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam for control of antimuscarinic agitation. Richmond Agitation Sedation Scores (RASS) will be compared throughout treatment protocol. The Richmond Agitation-Sedation Scale (RASS) measures sedation and agitation. Possible scores range from -5 (unarousable) to 0 (alert \\& calm) to +4 (combative). Scores closer to 0 indicate a better outcome for this measurement.'}, {'measure': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: Before Bolus', 'timeFrame': 'Baseline, immediately before bolus', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.'}, {'measure': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: After Bolus', 'timeFrame': 'Immediately after bolus, up to 10 minutes post-Baseline', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.'}, {'measure': 'Comparison of the Effectiveness in Control of Delirium Between Physostigmine and Lorazepam: 4 Hours', 'timeFrame': '4 hours', 'description': 'Determine the effectiveness of physostigmine as compared with lorazepam in the reversal of antimuscarinic delirium. Confusion Assessment Method for the ICU (CAM-ICU) scores will be evaluated throughout the study. This measurement is a dichotomous outcome ("yes" or "no" for presence of delirium is indicated rather than a score). The number of participants exhibiting delirium is reported.'}], 'secondaryOutcomes': [{'measure': 'Safety and Effectiveness of Physostigmine Infusion in the Setting of Antimuscarinic Toxidrome.', 'timeFrame': 'Up to 4 hours', 'description': 'Evaluation of clinical antimuscarinic symptoms, along with presence of any adverse effects, during the infusion to report tolerability, safety profile, and effectiveness of the infusion. the number of participants exhibiting adverse events will be reported, by type.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anticholinergics Toxicity']}, 'descriptionModule': {'briefSummary': 'Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or benzodiazepines.\n\nAlthough the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly despite evidence of safety and efficacy. To demonstrate the utility and safety of physostigmine, the investigators propose a randomized clinical trial of physostigmine compared to benzodiazepine for antimuscarinic toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=10 and \\< 18 years\n* Present to the Emergency Department or Intensive Care Unit for an antimuscarinic toxidrome from either a pharmaceutical agent such as antihistamine overdose, or natural toxins or products such as Datura stramonium\n* Antimuscarinic toxidrome will be defined with at least one central nervous system agitation effect (agitation, delirium, visual hallucinations, mumbling incomprehensible speech), and at least 2 peripheral nervous system adverse effect (mydriasis, dry mucus membranes, dry axillae, tachycardia, decreased bowel sounds).\n* Patients will also be required to have a RASS score of +2 to +4 on initial assessment.\n\nExclusion Criteria:\n\n* History of seizures or seizure during acute clinical course\n* History of asthma or wheezing during clinical course Bradycardia (Heart Rate \\<60)\n* Concomitant use of atropine or choline ester or depolarizing neuromuscular blocker during present illness and hospital course\n* Diabetes gangrene, known intestinal obstruction or urogenital tract, vagotonic state\n* QRS interval \\> 120 ms on electrocardiogram\n* Known to be pregnant at the time of enrollment\n* Known ward of the state'}, 'identificationModule': {'nctId': 'NCT03090620', 'acronym': 'TAAT', 'briefTitle': 'Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome', 'orgStudyIdInfo': {'id': '16-1730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physostigmine', 'description': 'Physostigmine 0.02 mg/kg IV bolus (max of 2 mg), which can be repeated at 10 minutes, followed by a 0.02 mg/kg/hr (max of 2 mg/hr) infusion for 4 hours.', 'interventionNames': ['Drug: Physostigmine']}, {'type': 'EXPERIMENTAL', 'label': 'Lorazepam', 'description': 'Lorazepam 0.05 mg/kg IV bolus (max 2 mg), which can be repeated at 10 minutes if inadequate patient response, followed by a Normal Saline infusion for 4 hours.', 'interventionNames': ['Drug: Lorazepam']}], 'interventions': [{'name': 'Physostigmine', 'type': 'DRUG', 'description': 'Administration of physostigmine bolus followed by an infusion', 'armGroupLabels': ['Physostigmine']}, {'name': 'Lorazepam', 'type': 'DRUG', 'description': 'Administration of lorazepam bolus followed by normal saline infusion', 'armGroupLabels': ['Lorazepam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "University of Colorado Anschutz Medical Campus, Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'George S Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Clinical Toxicology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}