Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT01146405
Status:
UNKNOWN
Last Update Posted:
2011-02-09
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Memory During Anesthesia: the Role of Stress Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood and serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-08', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hormones levels', 'timeFrame': '5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg', 'description': 'The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.'}, {'measure': 'Hormones levels', 'timeFrame': 'Baseline', 'description': 'The blood sample will be taken 30 minutes before induction of anaesthesia to determine baseline hormones (cortisol + prolactine) levels.'}], 'secondaryOutcomes': [{'measure': 'Remifentanil concentration', 'timeFrame': '5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg', 'description': 'One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).'}, {'measure': 'Memory', 'timeFrame': 'Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia', 'description': 'Patients will be asked to associate with keywords the first thing that comes them to mind (implicit memory). Also eplicit memory and dreams recall will be tested at the same time. The content of intraoperative dreams (confirmed by a brief post-anesthesia interview) will be analyzed using the 5-point Likert scale.'}, {'measure': 'Primary auditory cortex activation', 'timeFrame': '5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg', 'description': 'ERP-EEG monitoring system with 128 channel EGI GES300'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic'], 'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': '1. To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.\n2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.\n3. To investigate whether, in patients receiving auditory stimulation, there is a correlation between hormones levels (cortisol+prolactin), serum remifentanil concentration and detection of implicit memory.\n4. To investigate the presence of primary auditory cortex activation (temporal lobe) in patients with implicit memory and in those with dreams recall using the EEG-ERP 128 channels GES300 EGI system.', 'detailedDescription': 'Patients from group A, during maintenance of anesthesia, at the time of trocar insertion, will listen (via MP3) a piece of one of two stories, "Puss in Boots" and "Pinocchio", each followed by four keywords. In group B, patients will be isolated from the sounds of the operating room using specific headphones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients sheduled for minor elective laparoscopic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years old\n* Class-ASA Physical Status I-II\n\nExclusion Criteria:\n\n* Psychiatric or neurological disorders and/or hearing disorders\n* Obesity (Body Mass Index \\> 30)\n* Drug addiction, alcoholism\n* Patients with an education level below middle school\n* Patients with difficulty in understanding the Italian language\n* Patients treated with corticosteroids and/or estrogens, pregnant patients and patients suffering from hypercorticism'}, 'identificationModule': {'nctId': 'NCT01146405', 'briefTitle': 'Memory During Anesthesia: the Role of Stress Hormones', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'orgStudyIdInfo': {'id': '918/09'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Aceto, MD', 'role': 'CONTACT', 'email': 'etico@rm.unicatt.it'}, {'name': 'Liliana Sollazzi, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paola Aceto, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catholic University of Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Liliana Sollazzi', 'oldOrganization': 'Catholic University of Sacred Heart'}}}}