Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-07 @ 4:54 AM
Study NCT ID:
NCT07259460
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia', 'timeFrame': 'PSi values and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery', 'description': 'Evaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values'}, {'measure': 'Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesia', 'timeFrame': 'EEG power spectrum and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery', 'description': 'Evaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum'}, {'measure': 'Effects of Dexmedetomidine on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia', 'timeFrame': 'ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery', 'description': 'Evaluate if dxmedetomidine variations during general anesthesia has an impact on the ANI values'}], 'secondaryOutcomes': [{'measure': 'Analgesia Nociception Index (ANI) values and postoperative pain', 'timeFrame': 'Numeric Rating Scale (NRS) will be evaluated after the end of surgery and 24 hours after the end of surgery and compared to ANI values after 24 hours', 'description': 'Evaluate if different ANI values at the same dexmedetomidine concentrations has an impact on postoperative pain'}, {'measure': 'Patient State Index (PSi) values and postoperative delirium', 'timeFrame': 'Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours', 'description': 'Evaluate if different PSi values at the same dexmedetomidine concentrations has an impact on postoperative delirium'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adjuvants, Anesthesia']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine Target Controlled infusion (TCI, Dyck model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil TCI (Eleveld model) has not been investigate yet.\n\nAuthors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) and pupillometry values during maintenance during TIVA-TCI with Propofol, Remifentanil and Dexmedetomidine.', 'detailedDescription': 'The effects of Dexmedetomidine administered via Target-Controlled Infusion (TCI, Dyck model) on neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil (TCI, Eleveld model) have not yet been investigated.\n\nThe authors aim to systematically evaluate the impact of adding Dexmedetomidine on key neuromonitoring parameters commonly used in clinical anesthesia during the maintenance phase of TIVA-TCI. Specifically, the study will assess:\n\nPatient State Index (PSi) as a measure of the hypnotic state;\n\nElectroencephalographic (EEG) power spectrum, to identify changes in cortical activity patterns associated with Dexmedetomidine administration;\n\nAnalgesia Nociception Index (ANI), to evaluate potential modifications in the analgesia-nociception balance;\n\nPupillometry, to quantify autonomic and pupillary responses to stimuli.\n\nThis investigation aims to determine whether the addition of Dexmedetomidine using a TCI approach produces predictable and clinically relevant alterations in neurophysiological monitoring during anesthesia with Propofol and Remifentanil. Ultimately, the study seeks to support more precise drug titration and enhance patient safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing brast cancer surgery with general anesthesia with Propofol, remifentanil and Dexmedetomidine TCI will be recruited', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol and Rmifntanil (Eleveld model) and Dexmedetomidine (Dyck model)\n\nExclusion Criteria:\n\n* Neurological disease\n* Psychiatric disease\n* Obesity\n* Regional anesthesia performed'}, 'identificationModule': {'nctId': 'NCT07259460', 'briefTitle': 'Effects of Dexmedetomidine Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effects of Dexmedetomidine Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum, Analgesia Nociception Index nd Pupillomtry Values During Total Intravenous Anesthesia With Propofol TCI', 'orgStudyIdInfo': {'id': 'DexMAST'}}, 'contactsLocationsModule': {'locations': [{'zip': '31100', 'city': 'Treviso', 'state': 'TV', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Linassi', 'role': 'CONTACT', 'email': 'federico.linassi@gmail.com'}], 'facility': 'Treviso Regional Hospital', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}], 'centralContacts': [{'name': 'Federico Linassi, MD, PhD', 'role': 'CONTACT', 'email': 'federico.linassi@gmail.com', 'phone': '0422322440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Principal investigator', 'investigatorFullName': 'Federico Linassi', 'investigatorAffiliation': 'University of Padova'}}}}