Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04679818
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2020-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postoperative Consequences of Intraoperative NOL Titration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ruetzlk@ccf.org', 'phone': '216 636-0561', 'title': 'Kurt Ruetzler', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the start of surgery to the initial hour of recovery.', 'eventGroups': [{'id': 'EG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Scores at 10-minute Intervals for the Initial Hour of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'title': 'Time point 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.0'}]}]}, {'title': 'Time point 2', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.0'}]}]}, {'title': 'Time point 3', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '7.0'}]}]}, {'title': 'Time point 4', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}, {'title': 'Time point 5', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}, {'title': 'Time point 6', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '0.895', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.08', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '1.58', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'title': 'Time point 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.0'}]}]}, {'title': 'Time point 2', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.0'}]}]}, {'title': 'Time point 3', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.84', 'ciLowerLimit': '-2.66', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At 10-minute intervals during the first 30 minutes after extubation.', 'description': 'Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'units': 'Measurements', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.565', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.65', 'statisticalMethod': 'generalized linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.', 'unitOfMeasure': 'measurements', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'SECONDARY', 'title': 'Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'units': 'Measurements', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.62', 'ciUpperLimit': '3.54', 'statisticalMethod': 'Generalized linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 10-minute intervals during the first 30 minutes after extubation.', 'description': 'Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.', 'unitOfMeasure': 'measurements', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Analgesic Rescue Boluses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'During the first 60 minutes after extubation.', 'description': 'Number of analgesic rescue boluses in the first 60 minutes after extubation.', 'unitOfMeasure': 'Number of boluses', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ramsay Scores During the First 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'units': 'Measurements', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'title': '1 (Patient is anxious and agitated or restless)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 (Patient is co- operative, oriented, and tranquil)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': '3 (Patient responds to commands only)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': '4 (Patient exhibits brisk response to light glabellar tap or loud auditory stimulus)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.82', 'statisticalMethod': 'proportional odds model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \\<1.2.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.', 'unitOfMeasure': 'Measurements', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Effect on the Time to Emergence From Anesthesia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '22'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.63', 'statisticalMethod': 'Cox proportional hazards regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.', 'description': 'Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 Nociception level (NOL) under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg actual body weight (ABW), up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PMD-200 NOL Group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients\n\nPMD-200 Nol-guided opioid administration: PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.\n\nRoutine opioid management: Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '16', 'groupId': 'BG000'}, {'value': '54', 'spread': '15', 'groupId': 'BG001'}, {'value': '56', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171', 'spread': '11', 'groupId': 'BG000'}, {'value': '171', 'spread': '10', 'groupId': 'BG001'}, {'value': '171', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '19', 'groupId': 'BG000'}, {'value': '82', 'spread': '23', 'groupId': 'BG001'}, {'value': '80', 'spread': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '5', 'groupId': 'BG000'}, {'value': '28', 'spread': '6', 'groupId': 'BG001'}, {'value': '28', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Procedure type', 'classes': [{'title': 'Open', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Laparoscopy', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgery type', 'classes': [{'title': 'Colorectal', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Hernia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA (American Society of Anesthesiologist) physical status', 'classes': [{'title': 'I (healthy)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'II (mild systemic disease)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'III (severe systemic disease)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA I: A normal healthy patient (better) ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease (worse)', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative opioid use', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative antihypertension medication use', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-03', 'size': 363977, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-29T11:41', 'hasProtocol': True}, {'date': '2021-03-05', 'size': 201458, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-29T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2020-12-17', 'resultsFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-18', 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Analgesic Rescue Boluses', 'timeFrame': 'During the first 60 minutes after extubation.', 'description': 'Number of analgesic rescue boluses in the first 60 minutes after extubation.'}, {'measure': 'Ramsay Scores During the First 60 Minutes', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.'}, {'measure': 'Treatment Effect on the Time to Emergence From Anesthesia.', 'timeFrame': 'From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.', 'description': 'Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation'}], 'primaryOutcomes': [{'measure': 'Pain Scores at 10-minute Intervals for the Initial Hour of Recovery', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.'}, {'measure': 'Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery', 'timeFrame': 'At 10-minute intervals during the first 30 minutes after extubation.', 'description': 'Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.'}], 'secondaryOutcomes': [{'measure': 'Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery', 'timeFrame': 'At 10-minute intervals during the first 60 minutes after extubation.', 'description': 'Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.'}, {'measure': 'Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery', 'timeFrame': 'At 10-minute intervals during the first 30 minutes after extubation.', 'description': 'Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia; Adverse Effect']}, 'referencesModule': {'references': [{'pmid': '36727855', 'type': 'DERIVED', 'citation': 'Ruetzler K, Montalvo M, Bakal O, Essber H, Rossler J, Mascha EJ, Han Y, Ramachandran M, Keebler A, Turan A, Sessler DI. Nociception Level Index-Guided Intraoperative Analgesia for Improved Postoperative Recovery: A Randomized Trial. Anesth Analg. 2023 Apr 1;136(4):761-771. doi: 10.1213/ANE.0000000000006351. Epub 2023 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.', 'detailedDescription': 'Previous work has shown that NOL (Nociception Level) accurately quantifies nociception during general anesthesia.6 Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the PACU (Post-Anesthesia Care Unit). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults having major non-cardiac surgery expected to last ≥2 hours\n* American Society of Anesthesiologists physical status 1-3\n* Age 21-85 years old\n* Planned endotracheal intubation\n\nExclusion Criteria:\n\n* Planned neuraxial or regional block\n* Clinician preference for an opioid other than, or in addition to, fentanyl\n* Non-sinus heart\n* Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea\n* Lack of English language fluency\n* Routine user of psychoactive drugs other than opioids\n* Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.\n* Intracranial surgery.\n* BMI \\> 40'}, 'identificationModule': {'nctId': 'NCT04679818', 'briefTitle': 'Postoperative Consequences of Intraoperative NOL Titration', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Postoperative Consequences of Intraoperative NOL Titration', 'orgStudyIdInfo': {'id': '19-1646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PMD-200 NOL group', 'description': 'Clinicians will titrate fentanyl to keep PMD-200 (Pain Monitoring Device) Nociception level (NOL) under 25 - always using good clinical judgement for individual patients', 'interventionNames': ['Device: PMD-200 Nol-guided opioid administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Clinicians will be blinded to PMD-200 Nociception level (NOL) monitoring and use clinical judgement to determine how much fentanyl should be given, and when.', 'interventionNames': ['Drug: Routine opioid management']}], 'interventions': [{'name': 'Routine opioid management', 'type': 'DRUG', 'otherNames': ['Fentanyl'], 'description': 'Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.', 'armGroupLabels': ['Control Group']}, {'name': 'PMD-200 Nol-guided opioid administration', 'type': 'DEVICE', 'otherNames': ['PMD-200 NOL'], 'description': 'PMD-200 Nociception level (NOL) values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends', 'armGroupLabels': ['PMD-200 NOL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Kurt Ruetzler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}