Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01633320
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emmanuel.boselli@chu-lyon.fr', 'phone': '+334711689', 'title': 'Dr Emmanuel Boselli', 'organization': 'Edouard Herriot hôspital Anaesthesia and intensive care'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NRS<=3', 'description': 'Patients with numerical rating scale \\<=3 at arrival in PACU', 'otherNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NRS>3', 'description': 'Patients with numerical rating scale pain score \\>3 at arrival in PACU', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analgesia/Nociception Index (ANI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS<=3', 'description': 'Patients with numerical rating scale \\<=3 at arrival in PACU'}, {'id': 'OG001', 'title': 'NRS>3', 'description': 'Patients with numerical rating scale pain score \\>3 at arrival in PACU'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '17', 'groupId': 'OG000'}, {'value': '49', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At arrival in post-operative care unit (PACU) or 10 min after extubation', 'description': 'The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Scores on a 0-10 Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS<=3', 'description': 'Patients with numerical rating scale \\<=3 at arrival in PACU'}, {'id': 'OG001', 'title': 'NRS>3', 'description': 'Patients with numerical rating scale pain score \\>3 at arrival in PACU'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '1', 'groupId': 'OG000'}, {'value': '5', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At arrival in PACU or 10 min after extubation', 'description': 'Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\\<3 corresponds to no or mild pain NRS\\>=3 corresponds to moderate to severe pain NRS\\>=7 corresponds to severe pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NRS<=3 (no or Mild Pain)', 'description': 'Patients with numerical rating pain scale \\<=3 at arrival in PACU'}, {'id': 'FG001', 'title': 'NRS>3 (Moderate to Severe Pain)', 'description': 'Patients with numerical rating scale pain score \\>3 at arrival in PACU'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study performed between June and July 2012 at Édouard Herriot university hospital,Lyon, France.\n\n200 American Society of Anesthesiologists physical status I-II patients undergoing general anesthesia were included. The procedures performed were ear, nose and throat surgery or endoscopy and plastic surgery.', 'preAssignmentDetails': 'No patient were excluded from the trial before assignment to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NRS<=3', 'description': 'Patients with numerical rating scale \\<=3 at arrival in PACU'}, {'id': 'BG001', 'title': 'NRS>3', 'description': 'Patients with numerical rating scale pain score \\>3 at arrival in PACU'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '18', 'groupId': 'BG000'}, {'value': '44', 'spread': '15', 'groupId': 'BG001'}, {'value': '43', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2012-06-28', 'resultsFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-13', 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia/Nociception Index (ANI)', 'timeFrame': 'At arrival in post-operative care unit (PACU) or 10 min after extubation', 'description': 'The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.'}, {'measure': 'Pain Scores on a 0-10 Numeric Rating Scale (NRS)', 'timeFrame': 'At arrival in PACU or 10 min after extubation', 'description': 'Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\\<3 corresponds to no or mild pain NRS\\>=3 corresponds to moderate to severe pain NRS\\>=7 corresponds to severe pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Analgesia/Nociception index'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.', 'detailedDescription': 'Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.\n\nAssessment of the performance of ANI to detect NRS\\>3 and NRS\\>=7 by building ROC curves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients underoing surgical or endoscopic procedures performed on general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* surgical or endoscopic procedures performed on general anesthesia\n\nExclusion Criteria:\n\n* age \\<18 yrs or \\>75 yrs\n* arrythmia\n* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes\n* psychiatric diseases\n* autonomic nervous system (ANS) disorders\n* inability to understand the verbal rating pain scale.'}, 'identificationModule': {'nctId': 'NCT01633320', 'briefTitle': 'Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study', 'orgStudyIdInfo': {'id': 'CPP 2012-021 B'}}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Lionel Bouvet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Gérard Bégou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Rabia Dabouz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Christophe Magnin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Bernard Allaouchiche, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Emmanuel Boselli, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Édouard Herriot hospital, HCL'}, {'name': 'Mirela-Daniela Ionescu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Édouard Herriot hospital, HCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Emmanuel Boselli', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}