Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT01342835
Status:
UNKNOWN
Last Update Posted:
2011-04-27
First Post:
2011-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia in Children After Propofol Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-26', 'studyFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '120 minutes', 'description': 'The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity'}], 'secondaryOutcomes': [{'measure': 'recovery time', 'timeFrame': '120 minutes', 'description': 'Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia'}, {'measure': 'adverse effects', 'timeFrame': '0-120 minutes', 'description': 'Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propofol', 'sevoflurane', 'postoperative pain', 'children'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.', 'detailedDescription': 'In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is 3- 6 years old\n* Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent\n\nExclusion Criteria:\n\n* allergy to any of the drugs\n* preoperative anxiety\n* postoperative agitation\n* ASA physical status \\>II"}, 'identificationModule': {'nctId': 'NCT01342835', 'acronym': 'propan', 'briefTitle': 'Postoperative Analgesia in Children After Propofol Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Clinical Centre of Kosova'}, 'officialTitle': 'Postoperative Analgesia in Children After Propofol Anesthesia', 'orgStudyIdInfo': {'id': 'UCCK-55'}, 'secondaryIdInfos': [{'id': 'RAA12', 'type': 'REGISTRY', 'domain': 'RAA12'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'drug: propofol', 'description': 'Drug:Propofol and sevoflurane The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane group:sevoflurane', 'description': 'Drug:Sevoflurane and Propofol Mask induction is perform with sevoflurane (4-6%) follow by 1.5-2% sevoflurane in a 50:50 mixture of N2O and O2.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan', 'Sevorane'], 'description': 'The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.', 'armGroupLabels': ['Sevoflurane group:sevoflurane', 'drug: propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Pristina', 'state': 'Kosovo', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Antigona Hasani, MD,MSC', 'role': 'CONTACT', 'email': 'antigona.hasani@gmail.com', 'phone': '+38138500600', 'phoneExt': '3015'}], 'facility': 'University Clinical Center of Kosovo'}], 'centralContacts': [{'name': 'Antigona Hasani, MD, MSC', 'role': 'CONTACT', 'email': 'antigona.hasani@gmail.com', 'phone': '+37744402781'}, {'name': 'Antiogna Hasani', 'role': 'CONTACT', 'phone': '+38138500600', 'phoneExt': '3015'}], 'overallOfficials': [{'name': 'Antigona Hasani, MD,MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinical Centre of Kosova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinical Centre of Kosova', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Antigona Hasani', 'oldOrganization': 'UCCK'}}}}