Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-04-11 @ 11:24 AM
Study NCT ID:
NCT00567957
Status:
UNKNOWN
Last Update Posted:
2007-12-05
First Post:
2007-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil for General Anesthesia in Preeclamptics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-04', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Induction to post-intubation period'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Induction to delivery'}, {'measure': 'Amount of additional drugs and fluids if required', 'timeFrame': 'Induction to delivery'}, {'measure': 'Evaluation of the newborn', 'timeFrame': 'Within 10 min following delivery'}]}, 'conditionsModule': {'keywords': ['pre-eclampsia', 'remifentanil', 'anesthesia, general', 'analgesics, opioid', 'anesthetics, intravenous', 'Cesarean section', 'newborn', 'maternal haemodynamic'], 'conditions': ['Pre-Eclampsia', 'Hypertension, Pregnancy-Induced', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '16394684', 'type': 'BACKGROUND', 'citation': 'Ngan Kee WD, Khaw KS, Ma KC, Wong AS, Lee BB, Ng FF. Maternal and neonatal effects of remifentanil at induction of general anesthesia for cesarean delivery: a randomized, double-blind, controlled trial. Anesthesiology. 2006 Jan;104(1):14-20. doi: 10.1097/00000542-200601000-00004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.', 'detailedDescription': 'General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.\n\nRecently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia\n\nExclusion Criteria:\n\n* Known allergy to study drugs\n* Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight \\<400 gr, gestational week\\<24 weeks)\n* Known cardiac disease diagnosed prior to pregnancy\n* Known drug abuse in the parturient\n* Multifetal gestation\n* Anticipated difficult airway management (mask ventilation and/or endotracheal intubation).'}, 'identificationModule': {'nctId': 'NCT00567957', 'briefTitle': 'Remifentanil for General Anesthesia in Preeclamptics', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients', 'orgStudyIdInfo': {'id': 'RP01'}, 'secondaryIdInfos': [{'id': 'BYP-1833'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Saline starting before induction till entry to abdominal cavity', 'interventionNames': ['Drug: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R', 'description': 'Remifentanil starting before induction till entry to abdominal cavity', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': '1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion', 'armGroupLabels': ['R']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['% 0.9 NaCl'], 'description': 'same volume iv bolus before induction followed by same volume infusion', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34390', 'city': 'Istanbul', 'state': 'Capa', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept.', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tulay Ozkan Seyhan, Associate Prof.', 'role': 'CONTACT', 'email': 'tulay2000@e-kolay.net', 'phone': '+90 212 631 87 67'}, {'name': 'Mukadder Orhan Sungur, Staff', 'role': 'CONTACT', 'email': 'mosungur@istanbul.edu.tr', 'phone': '+90 212 631 87 67'}], 'overallOfficials': [{'name': 'Tulay Ozkan Seyhan, Associate Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tulay Ozkan Seyhan', 'oldOrganization': 'Istanbul University- Istanbul Faculty of Medicine, Dept. of Anesthesiology'}}}}