Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT01955135
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2013-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia for Retinopathy of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'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'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2013-09-04', 'studyFirstSubmitQcDate': '2013-09-27', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory failure after retinopathy of prematurity surgery in premature infants.', 'timeFrame': '1 Day (From end of anaesthesia till discharge from the recovery room )', 'description': 'Most of premature infants have chronic lung disease, for this reason endotracheal intubation causes some problems, because they have irritable airway. Administration of sedation and avoiding endotracheal intubation can be better for postsurgical outcomes.\n\nHow many infants needed endotracheal intubation and mechanical ventilation were recorded.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '1 Day (From start of anaesthesia till discharge from the operation room)', 'description': 'non invasive blood pressure measured'}, {'measure': 'Heart rate', 'timeFrame': '1 Day (From start of anaesthesia till discharge from the recovery room )', 'description': 'heart rate per minute were recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prematurity, Retinopathy, propofol, ketamine, sedation'], 'conditions': ['Retinopathy']}, 'descriptionModule': {'briefSummary': 'Premature infants experience more respiratory problems after surgical procedures. The investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.', 'detailedDescription': '60 patients who underwent laser surgery due to retinopathy of prematurity (ROP) were included in the study. The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen. Our primary objective was to evaluate the need for post-operative mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Weeks', 'minimumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP\n\nExclusion Criteria:\n\n* The exclusion criteria were patients requiring inotropic support,\n* the need for mechanical ventilation or intubation in the 3 days prior to the operation,\n* known allergy or hypersensitivity reaction to ketamine and propofol,\n* age ˃40 weeks.'}, 'identificationModule': {'nctId': 'NCT01955135', 'briefTitle': 'Anesthesia for Retinopathy of Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'DECREASING THE NEED FOR MECHANICAL VENTILATION AFTER RETINOPATHY OF PREMATURITY SURGERY: Sedation vs General Anesthesia', 'orgStudyIdInfo': {'id': '2010 /145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sedation', 'description': 'The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance.', 'interventionNames': ['Drug: Ketamine', 'Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia', 'description': 'In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['ketalar, 50mg/ml'], 'description': '1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation', 'armGroupLabels': ['sedation']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['sevorein'], 'description': 'anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen', 'armGroupLabels': ['general anesthesia']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['pofol'], 'description': '1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol', 'armGroupLabels': ['sedation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AYŞE ÜLGEY, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TC Erciyes University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ayse Ulgey', 'investigatorAffiliation': 'TC Erciyes University'}}}}