Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT06884657
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Mannitol on Propofol Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008353', 'term': 'Mannitol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum propofol levels', 'timeFrame': 'Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)', 'description': 'Blood samples will be taken during study and then propofol levels will measure at the end of study.'}], 'secondaryOutcomes': [{'measure': 'Urine propofol levels', 'timeFrame': 'The sample collection will continue till the 100th minutes of anesthesia (TIVA)', 'description': 'Urine samples will take during total intravenous anesthesia (TIVA). And then urine propofol levels will measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mannitol Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol. Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 20 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels.', 'detailedDescription': 'The participants will divide into the two groups. Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, (Mannitol group) and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol (Control Group). Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 20 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels. Beside to standard monitoring invasive hemodynamic monitorization (cardiac output, cardiac index, stroke volume variability) and bispectral index will apply to the all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) II participants\n* supratentorial tumor surgery\n* eligible for mannitol use\n* eligible for Total intravenous anesthesia (TIVA)\n\nExclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) III and upper\n* Chronic kidney failure\n* sepsis\n* multiorgan failure'}, 'identificationModule': {'nctId': 'NCT06884657', 'acronym': 'level', 'briefTitle': 'Effect of Mannitol on Propofol Level', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Propofol Level at TCI During Mannitol', 'orgStudyIdInfo': {'id': 'mannitol'}, 'secondaryIdInfos': [{'id': 'Anesthesia', 'type': 'REGISTRY', 'domain': 'Çukurova University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mannitol', 'description': '2.5 ml/kg (0.5 g/kg) Mannitol will be given to all patients 15 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.', 'interventionNames': ['Drug: mannitol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': '2.5 ml/kg saline will be given to patients 15 minutes after induction and the infusion will be adjusted to be 10 minutes.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'mannitol', 'type': 'DRUG', 'description': '2.5 mg/kg Mannitol will be given intravenously', 'armGroupLabels': ['Mannitol']}, {'name': 'Saline', 'type': 'OTHER', 'description': '2.5 ml/kg saline will be given as plasebo', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Çukurova', 'state': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ebru Biricik', 'role': 'CONTACT', 'email': 'ebrubiricik01@gmail.com', 'phone': '05052420223'}], 'facility': 'Çukurova University'}], 'centralContacts': [{'name': 'Ebru Biricik', 'role': 'CONTACT', 'email': 'ebrubiricik01@gmail.com', 'phone': '+905052420223'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'ebru biricik', 'investigatorAffiliation': 'Cukurova University'}}}}