Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01048658
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2010-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'whru@ohsu.edu', 'phone': '503-494-3666', 'title': 'Dr. Rosenne Botha', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During and post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.', 'otherNumAtRisk': 80, 'otherNumAffected': 3, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.', 'otherNumAtRisk': 80, 'otherNumAffected': 1, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cervical laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unterine atony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Blood loss and unterine atony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'OG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes', 'description': 'Provider report for need to intervene due to blood loss (yes/no)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'OG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of uterine evacuation, an average of 7.1 minutes', 'description': 'Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'OG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time of speculum place to time of speculum removal, an average of 7.1 minutes', 'description': 'Length of procedure from time of speculum placement to time of speculum removal, in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Side Effects (Nausea, Dizziness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'OG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-procedure, within 30 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient and Provider Satisfaction With Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'OG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'classes': [{'title': 'Provider Satisfaction', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Patient Satisfaction', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-procedure, within 30 minutes', 'description': 'Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'FG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.\n\nSevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'BG001', 'title': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.\n\nNo Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2010-01-12', 'resultsFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-07', 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)', 'timeFrame': 'At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes', 'description': 'Provider report for need to intervene due to blood loss (yes/no)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)', 'timeFrame': 'At time of uterine evacuation, an average of 7.1 minutes', 'description': 'Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).'}, {'measure': 'Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)', 'timeFrame': 'Time of speculum place to time of speculum removal, an average of 7.1 minutes', 'description': 'Length of procedure from time of speculum placement to time of speculum removal, in minutes.'}, {'measure': 'Number of Participants Experiencing Side Effects (Nausea, Dizziness)', 'timeFrame': 'Post-procedure, within 30 minutes'}, {'measure': 'Patient and Provider Satisfaction With Anesthesia', 'timeFrame': 'Post-procedure, within 30 minutes', 'description': 'Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sevoflurane', 'anesthesia', 'abortion', 'blood loss'], 'conditions': ['Blood Loss', 'Anesthesia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Socio-Economic Factbook, S.A. Department, Editor. 1993, American College of Surgeons: Chicago, IL.'}, {'type': 'BACKGROUND', 'citation': "Paul, M., A Clinician's Guide to Medical and Surgical Abortion. 1999, New York, New York: Church Livingstone."}, {'pmid': '6866362', 'type': 'BACKGROUND', 'citation': 'Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90.'}, {'pmid': '12336808', 'type': 'BACKGROUND', 'citation': 'Method, weeks of gestation key in abortion complications. Contracept Technol Update. 1980 Oct;1(7):96-7.'}, {'pmid': '4058825', 'type': 'BACKGROUND', 'citation': 'MacKay HT, Schulz KF, Grimes DA. Safety of local versus general anesthesia for second-trimester dilatation and evacuation abortion. Obstet Gynecol. 1985 Nov;66(5):661-5.'}, {'pmid': '19014796', 'type': 'BACKGROUND', 'citation': "O'Connell K, Jones HE, Lichtenberg ES, Paul M. Second-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2008 Dec;78(6):492-9. doi: 10.1016/j.contraception.2008.07.011. Epub 2008 Sep 4."}, {'pmid': '2816239', 'type': 'BACKGROUND', 'citation': "Abboud TK, D'Onofrio L, Reyes A, Mosaad P, Zhu J, Mantilla M, Gangolly J, Crowell D, Cheung M, Afrasiabi A, et al. Isoflurane or halothane for cesarean section: comparative maternal and neonatal effects. Acta Anaesthesiol Scand. 1989 Oct;33(7):578-81. doi: 10.1111/j.1399-6576.1989.tb02970.x."}, {'pmid': '4025771', 'type': 'BACKGROUND', 'citation': 'West SL, Moore CA, Gillard M, Browne PD. Anaesthesia for suction termination of pregnancy. Anaesthesia. 1985 Jul;40(7):669-72. doi: 10.1111/j.1365-2044.1985.tb10948.x.'}, {'pmid': '3936528', 'type': 'BACKGROUND', 'citation': 'Collins KM, Plantevin OM, Whitburn RH, Doyle JP. Outpatient termination of pregnancy: halothane or alfentanil-supplemented anaesthesia. Br J Anaesth. 1985 Dec;57(12):1226-31. doi: 10.1093/bja/57.12.1226.'}, {'pmid': '4393415', 'type': 'BACKGROUND', 'citation': 'Forrest WH Jr. Effects of anesthesia in therapeutic abortion. Anesthesiology. 1970 Jul;33(1):121-2. doi: 10.1097/00000542-197007000-00028. No abstract available.'}, {'pmid': '4391841', 'type': 'BACKGROUND', 'citation': 'Cullen BF, Margolis AJ, Eger EI 2nd. The effects of anesthesia and pulmonary ventilation on blood loss during elective therapeutic abortion. Anesthesiology. 1970 Feb;32(2):108-13. doi: 10.1097/00000542-197002000-00004. No abstract available.'}, {'pmid': '8706599', 'type': 'BACKGROUND', 'citation': 'Patel SS, Goa KL. Sevoflurane. A review of its pharmacodynamic and pharmacokinetic properties and its clinical use in general anaesthesia. Drugs. 1996 Apr;51(4):658-700. doi: 10.2165/00003495-199651040-00009.'}, {'pmid': '11782330', 'type': 'BACKGROUND', 'citation': 'Yamakage M, Tsujiguchi N, Chen X, Kamada Y, Namiki A. Sevoflurane inhibits contraction of uterine smooth muscle from pregnant rats similarly to halothane and isoflurane. Can J Anaesth. 2002 Jan;49(1):62-6. doi: 10.1007/BF03020420.'}, {'pmid': '12413258', 'type': 'BACKGROUND', 'citation': 'Turner RJ, Lambrost M, Holmes C, Katz SG, Downs CS, Collins DW, Gatt SP. The effects of sevoflurane on isolated gravid human myometrium. Anaesth Intensive Care. 2002 Oct;30(5):591-6. doi: 10.1177/0310057X0203000508.'}, {'pmid': '10051930', 'type': 'BACKGROUND', 'citation': 'Nathan N, Peyclit A, Lahrimi A, Feiss P. Comparison of sevoflurane and propofol for ambulatory anaesthesia in gynaecological surgery. Can J Anaesth. 1998 Dec;45(12):1148-50. doi: 10.1007/BF03012454.'}, {'pmid': '10673872', 'type': 'BACKGROUND', 'citation': 'Nelskyla K, Korttila K, Yli-Hankala A. Comparison of sevoflurane-nitrous oxide and propofol-alfentanil-nitrous oxide anaesthesia for minor gynaecological surgery. Br J Anaesth. 1999 Oct;83(4):576-9. doi: 10.1093/bja/83.4.576.'}, {'pmid': '16749414', 'type': 'BACKGROUND', 'citation': 'Karaman S, Akercan F, Aldemir O, Terek MC, Yalaz M, Firat V. The maternal and neonatal effects of the volatile anaesthetic agents desflurane and sevoflurane in caesarean section: a prospective, randomized clinical study. J Int Med Res. 2006 Mar-Apr;34(2):183-92. doi: 10.1177/147323000603400208.'}, {'pmid': '7598289', 'type': 'BACKGROUND', 'citation': 'Gambling DR, Sharma SK, White PF, Van Beveren T, Bala AS, Gouldson R. Use of sevoflurane during elective cesarean birth: a comparison with isoflurane and spinal anesthesia. Anesth Analg. 1995 Jul;81(1):90-5. doi: 10.1097/00000539-199507000-00018.'}, {'pmid': '15321492', 'type': 'BACKGROUND', 'citation': 'Toscano A, Pancaro C, Giovannoni S, Minelli G, Baldi C, Guerrieri G, Crowhurst JA, Peduto VA. Sevoflurane analgesia in obstetrics: a pilot study. Int J Obstet Anesth. 2003 Apr;12(2):79-82. doi: 10.1016/S0959-289X(02)00195-4.'}, {'pmid': '11239659', 'type': 'BACKGROUND', 'citation': 'Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. doi: 10.1016/s0029-7844(00)01148-0.'}, {'pmid': '18279684', 'type': 'BACKGROUND', 'citation': 'Turok DK, Gurtcheff SE, Esplin MS, Shah M, Simonsen SE, Trauscht-Van Horn J, Silver RM. Second trimester termination of pregnancy: a review by site and procedure type. Contraception. 2008 Mar;77(3):155-61. doi: 10.1016/j.contraception.2007.11.004. Epub 2008 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health \\& Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.', 'detailedDescription': "This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Participants' anesthesia will either be intravenous (IV) propofol, IV midazolam, IV fentanyl and nitrous oxide or this same regimen combined with sevoflurane during maintenance of anesthesia. Procedural outcomes, specifically those related to bleeding complications, including need to intervene for excess blood loss, will be recorded and analyzed to establish if such a relationship between use of sevoflurane and excess blood loss exists."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily requesting pregnancy termination\n* Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated by fetal biparietal diameter on clinic ultrasound.\n* Be able and willing to sign an informed consent and agree to terms of the study\n\nExclusion Criteria:\n\n* Known severe maternal respiratory disease or upper respiratory infection or sinus blockage\n* Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must have a documented normal international normalized ratio (INR) prior to procedure if on anticoagulation)\n* Multiple pregnancy\n* Fetal demise, if more than 2 weeks difference exists between known gestational age (by previous US dating) and gestational size on current ultrasound.\n* Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents'}, 'identificationModule': {'nctId': 'NCT01048658', 'briefTitle': 'Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures: Does it Increase Blood Loss and Interventions for Blood Loss and Why Do Anesthesiologists Choose to Use It?', 'orgStudyIdInfo': {'id': 'IRB - 5146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Sevoflurane', 'description': 'Subject receives standard of care drug regimens for anesthesia with this procedure.', 'interventionNames': ['Other: No Sevoflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Ultane'], 'description': 'Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.', 'armGroupLabels': ['Sevoflurane']}, {'name': 'No Sevoflurane', 'type': 'OTHER', 'description': 'Subject only standard of care drug regimens for anesthesia with this procedure.', 'armGroupLabels': ['No Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Lovejoy Surgicenter', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Rosanne Botha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master of Public Health Student, MD', 'investigatorFullName': 'Rosanne Botha', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}