Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT07276633
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Subanesthetic Dose Propofol Before Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changing Preoperative Anxiety Score (STAI)', 'timeFrame': '15 minutes (T1-T2)', 'description': 'Comparison of the State-Trait Anxiety Inventory (STAI) state anxiety score measured in the preoperative waiting room (T1) with the STAI score 15 minutes after the palming technique (T2). The difference between the two time points is analyzed to assess the anxiety-reducing effect of the intervention.'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic Parameter Changes', 'timeFrame': '15 minutes (T1-T2)', 'description': 'Changes in heart rate (HR) values between the T1 and T2 time points. The effect of the palming technique on hemodynamic stability is evaluated.'}, {'measure': 'Hemodynamic Parameter Changes', 'timeFrame': '15 minutes (T1-T2)', 'description': 'Changes in mean blood pressure values between the T1 and T2 time points. The effect of the palming technique on hemodynamic stability is evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Propofol', 'Postoperative Recovery', 'Patient Satisfaction', 'Emergence Agitation', 'Rhinoplasty', 'General Anesthesia Recovery', 'Sub-Anesthetic Dose'], 'conditions': ['Emergence Agitation', 'Rhinoplasty', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '23800983', 'type': 'BACKGROUND', 'citation': 'Kanaya A, Kuratani N, Satoh D, Kurosawa S. Lower incidence of emergence agitation in children after propofol anesthesia compared with sevoflurane: a meta-analysis of randomized controlled trials. J Anesth. 2014 Feb;28(1):4-11. doi: 10.1007/s00540-013-1656-y. Epub 2013 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates whether administering a low, sub-anesthetic dose of propofol before extubation can reduce emergence agitation and improve perioperative comfort in patients undergoing rhinoplasty. Emergence agitation refers to restlessness and confusion during early recovery from anesthesia, which may affect patient safety and surgical conditions. The study evaluates agitation levels, recovery characteristics, and patient-reported comfort following propofol administration compared with standard care.', 'detailedDescription': 'This study aims to evaluate whether administering a sub-anesthetic dose of propofol before extubation can reduce emergence agitation, enhance recovery characteristics, and improve patient comfort in adults undergoing rhinoplasty surgery. Emergence agitation is a common phenomenon during early recovery from general anesthesia and can involve restlessness, disorientation, and involuntary movements, potentially affecting patient safety and surgical outcomes. The study uses a randomized controlled design to compare peri-extubation responses between patients receiving low-dose propofol and those receiving standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65 years\n* Patients scheduled for rhinoplasty surgery\n* ASA physical status I-II\n* No respiratory tract infection\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Presence of any respiratory tract infection\n* Younger than 18 or older than 65\n* ASA III-IV\n* Known allergy to study medications\n* Predicted difficult intubation'}, 'identificationModule': {'nctId': 'NCT07276633', 'briefTitle': 'Use of Subanesthetic Dose Propofol Before Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Effect of Subanesthetic Dose Propofol Use Before Extubation on Recovery From Anesthesia, Agitation on Recovery, and Patient Satisfaction', 'orgStudyIdInfo': {'id': 'Subanesthetic Dose of Propofol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol Group', 'description': 'Sub-anesthetic dose of propofol (0.5 mg/kg) administered 10 minutes before extubation.', 'interventionNames': ['Other: Normal Saline (Placebo)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Normal saline administered 10 minutes before extubation.', 'interventionNames': ['Drug: Propofol (Sub-Anesthetic Dose)']}], 'interventions': [{'name': 'Propofol (Sub-Anesthetic Dose)', 'type': 'DRUG', 'otherNames': ['Normal saline administered pre-extubation'], 'description': 'Participants receive 0.5 mg/kg intravenous propofol as a single bolus 10 minutes before extubation.', 'armGroupLabels': ['Control Group']}, {'name': 'Normal Saline (Placebo)', 'type': 'OTHER', 'description': 'Participants receive an equivalent volume of normal saline 10 minutes before extubation.', 'armGroupLabels': ['Propofol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Yuzuncu Yil University, Dursun Odabas Medical Center', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Nureddin Yuzkat, Associate professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University Dursun Odabas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available because data sharing was not included in the informed consent and sharing such data could compromise patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Nureddin YUZKAT', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}