Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 11:23 AM
Study NCT ID:
NCT06822660
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dreams or Implicite Memorization Under OFA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implicite memorization incidence', 'timeFrame': 'From the operating room to one week after surgery', 'description': 'Through the isolated forearm technique and with the capacity of patients to recognize post operatively sounds that they have listened during the anesthesia, we evaluate the incidence of implicite memorization'}], 'secondaryOutcomes': [{'measure': 'explicite memorization', 'timeFrame': 'From the operating room to one week after surgery', 'description': 'Through the modified brice questionnaire, we assess the incidence of explicite memorization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implicite memorization', 'opioid free anesthesia', 'observationnal', 'monocentric', 'isolated forearm technique', 'explicite memorization'], 'conditions': ['Implicite Memorization']}, 'descriptionModule': {'briefSummary': 'The Dreams study is an observational study aimed at evaluating the incidence of connected awareness after intubation, intraoperative explicit and implicit memorization, and postoperative well-being in patients receiving general anesthesia without opioids.\n\nOutcomes\n\nThe primary objective is the evaluation of the incidence of connected consciousness after induction of general anesthesia without opioids and intubation. The secondary objectives are:\n\n* Implicit and explicit memorization after intubation and during the procedure\n* Post-operative well-being Pain in the recovery room and in the room, assessed by VAS;\n* Total consumption of analgesics (paracetamol, diclofenac, tramadol): data collected during discharge\n* Level of satisfaction, assessed using the EVAN scale\n* Duration of hospitalization\n* Estimated first mobilization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We study patients 18-75 aged undergoing laparoscopic robotic surgery ( prostatectomy, hysterectomy, colectomy) with an ASA status from 1 to 3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic robotic surgery\n* ASA score 1 to 3\n\nExclusion Criteria:\n\n* neurological and psychiatric diseases\n* reflect memory disorders\n* head trauma\n* hearing disorders\n* past or current use of medications affecting the central nervous system.'}, 'identificationModule': {'nctId': 'NCT06822660', 'acronym': 'Dreams', 'briefTitle': 'Dreams or Implicite Memorization Under OFA', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Dreams or Implicite Memorization Under OFA', 'orgStudyIdInfo': {'id': 'B0762024241010'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Florent Postal, Md', 'role': 'CONTACT', 'email': 'florent.postal@stpierre-bru.be', 'phone': '+32 470 044 986'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}