Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-28 @ 4:07 PM
Study NCT ID:
NCT03498820
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2018-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'up to 7 hours after the beginning of general anesthesia', 'description': 'total dose of remifentanil administered to the patient during general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Postoperative morphine consumption', 'timeFrame': 'obtained 24 hours after the end of general anesthesia', 'description': 'total dose of morphine administered to the patient to manage postoperative pain during the first 24 hours following surgery'}, {'measure': 'Persistent pain', 'timeFrame': ': obtained one month after surgery', 'description': 'phone interview asking the patient if she still feels pain related to the surgery'}, {'measure': 'Persistent pain', 'timeFrame': 'Obtained three months after surgery', 'description': 'phone interview asking the patient if she still feels pain related to the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia-Nociception Index (ANI)', 'General anesthesia', 'Opioids', 'Remifentanil', 'Pain', 'Monitoring'], 'conditions': ['Pain', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective gynecological surgery under general anesthesia\n* Duration of surgery 1-7 hours\n* Duration of hospital stay \\> 24 hours\n\nExclusion Criteria:\n\n* chronic pain\n* chronic analgesic medication\n* neurologic disease\n* psychiatric disease\n* history of addiction\n* kidney or liver failure\n* allergy to any anesthetic or analgesic drug\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT03498820', 'acronym': 'MONIDOL-ANI', 'briefTitle': 'Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use', 'orgStudyIdInfo': {'id': 'P171003J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Analgesia Nociception Index', 'description': 'Intraoperative remifentanil administration guided by the Analgesia Nociception Index', 'interventionNames': ['Device: Analgesia Nociception Index']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual practice', 'description': 'Intraoperative remifentanil administration managed in standard practice', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Analgesia Nociception Index', 'type': 'DEVICE', 'otherNames': ['ANI'], 'description': ': Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity', 'armGroupLabels': ['Analgesia Nociception Index']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'intravenous short-acting opioid routinely administered during general anesthesia', 'armGroupLabels': ['Usual practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': "Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nada SABOURDIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}