Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-24 @ 1:06 PM
Study NCT ID:
NCT00527332
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2007-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
Sponsor:
Organization:
Raw JSON
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Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '125'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 6 months after surgery', 'description': 'Duration of hospital stay defined as time from start anesthesia to leaving the hospital', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study were analyzed'}, {'type': 'SECONDARY', 'title': 'Occurrence and Degree of Postoperative Symptoms.', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Consumption of Analgesics and Antiemetics.', 'timeFrame': 'Within 6 months after surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Complications and Complication Rates.', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life and QALYs (Quality Adjusted Life Years).', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Sick Leave.', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Health-related Economy.', 'timeFrame': 'Within 6 months after the surgery', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spinal Anesthesia', 'description': 'Spinal anesthesia combined with intrathecal morphine'}, {'id': 'FG001', 'title': 'General Anesthesia', 'description': 'General anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spinal Anesthesia', 'description': 'Spinal anesthesia combined with intrathecal morphine'}, {'id': 'BG001', 'title': 'General Anesthesia', 'description': 'General anesthesia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', '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': 'Sweden', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2007-09-07', 'resultsFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-14', 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Hospital Stay.', 'timeFrame': 'Within 6 months after surgery', 'description': 'Duration of hospital stay defined as time from start anesthesia to leaving the hospital'}], 'secondaryOutcomes': [{'measure': 'Occurrence and Degree of Postoperative Symptoms.', 'timeFrame': 'Within 6 months after the surgery'}, {'measure': 'Postoperative Consumption of Analgesics and Antiemetics.', 'timeFrame': 'Within 6 months after surgery'}, {'measure': 'Complications and Complication Rates.', 'timeFrame': 'Within 6 months after the surgery'}, {'measure': 'Quality of Life and QALYs (Quality Adjusted Life Years).', 'timeFrame': 'Within 6 months after the surgery'}, {'measure': 'Sick Leave.', 'timeFrame': 'Within 6 months after the surgery'}, {'measure': 'The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.', 'timeFrame': 'Within 6 months after the surgery'}, {'measure': 'Health-related Economy.', 'timeFrame': 'Within 6 months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hospitalization', 'Postoperative care', 'Quality of Life', 'Health economy', 'Anesthesia. Spinal', 'Anesthesia, General'], 'conditions': ['Hysterectomy (MeSH nr: E04.950.300.399)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Vårdtid, funktionskapacitet och sjukskrivningstider efter hysterektomi. Nationella data från 6503 patienter opererade år 2000 och 2001. Återrapport från Nationella registret för kvalitetsutveckling inom gynekologisk kirurgi (Gynop-registret), SFOG, 2003.'}, {'pmid': '12095591', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.'}, {'pmid': '11222424', 'type': 'BACKGROUND', 'citation': 'Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.'}, {'pmid': '11516794', 'type': 'BACKGROUND', 'citation': 'Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6.'}, {'pmid': '16956334', 'type': 'BACKGROUND', 'citation': 'Persson P, Wijma K, Hammar M, Kjolhede P. Psychological wellbeing after laparoscopic and abdominal hysterectomy--a randomised controlled multicentre study. BJOG. 2006 Sep;113(9):1023-30. doi: 10.1111/j.1471-0528.2006.01025.x.'}, {'pmid': '12911451', 'type': 'BACKGROUND', 'citation': 'Ellstrom MA, Astrom M, Moller A, Olsson JH, Hahlin M. A randomized trial comparing changes in psychological well-being and sexuality after laparoscopic and abdominal hysterectomy. Acta Obstet Gynecol Scand. 2003 Sep;82(9):871-5. doi: 10.1080/j.1600-0412.2003.00216.x.'}, {'pmid': '22893770', 'type': 'DERIVED', 'citation': 'Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.'}, {'pmid': '22568450', 'type': 'DERIVED', 'citation': 'Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female between 18 and 60 years of age.\n* Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication.\n* At least one ovary planned to be preserved at the hysterectomy.\n* Can understand and communicate in Swedish\n* Accept participation after written and verbal information and after signed informed consent.\n* Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone.\n\nExclusion Criteria:\n\n* Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs\n* ASA classification ≥ Class 3\n* Postmenopausal women without HRT (hormone replacement therapy).\n* Suspected gynecological malignancy\n* Previously undergone bilateral oophorectomy\n* Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated.\n* Mentally or severly psychic disabled'}, 'identificationModule': {'nctId': 'NCT00527332', 'briefTitle': 'Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.', 'orgStudyIdInfo': {'id': 'EudraCT nr 2006-002520-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.', 'interventionNames': ['Drug: Bupivacain', 'Drug: Morphine', 'Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.', 'interventionNames': ['Drug: Propofol', 'Drug: Fentanyl', 'Drug: Rocuronbromid', 'Drug: Morphine']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['Marcain spinal tung.', 'ATC-code: N01BB01'], 'description': '5 mg/mL, 4 mL intrathecally as a single dos', 'armGroupLabels': ['A']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['Morfin Special', 'ATC-code: N02AA01'], 'description': '0.4 mg/mL; 0.5 mL intrathecally as a single dosage', 'armGroupLabels': ['A']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['ATC-code: N01AX10'], 'description': '2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery', 'armGroupLabels': ['A']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['ATC-code: N01AX10'], 'description': 'Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery', 'armGroupLabels': ['B']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['ATC-code:N01AH01'], 'description': '100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.', 'armGroupLabels': ['B']}, {'name': 'Rocuronbromid', 'type': 'DRUG', 'otherNames': ['Esmeron', 'ATC-code: M03AC09'], 'description': '0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery', 'armGroupLabels': ['B']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['ATC-code: N02AA01'], 'description': '5 mg is given IV (intravenously) before end of surgery', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57581', 'city': 'Eksjö', 'country': 'Sweden', 'facility': 'Eksjö Hospital', 'geoPoint': {'lat': 57.66643, 'lon': 14.97205}}, {'zip': '55185', 'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Ryhov Hospital', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '60182', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '33185', 'city': 'Värnamo', 'country': 'Sweden', 'facility': 'Värnamo Hospital', 'geoPoint': {'lat': 57.18604, 'lon': 14.04001}}], 'overallOfficials': [{'name': 'Preben Kjölhede, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Linköping'}, {'name': 'Lena Nilsson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, University Hospital, Linköping'}, {'name': 'Ninnie B. Wodlin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Linköping'}, {'name': 'Kenneth Krohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping'}, {'name': 'Lars Nordenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Vrinnevi Hospital, Norrköping'}, {'name': 'Mats D. Karlsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping'}, {'name': 'Veronica Annerhagen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Ryhov Hospital, Jönköping'}, {'name': 'Christina Gunnervik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, Värnamo Hospital'}, {'name': 'Magnus Trofast, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Värnamo Hospital'}, {'name': 'Tomasz Stypa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, Eksjö Hospital'}, {'name': 'Albert Sundberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Eksjö Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Preben Kjolhede', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Preben Kjolhede', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}