Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-03 @ 6:52 PM
Study NCT ID:
NCT02819661
Status:
UNKNOWN
Last Update Posted:
2018-05-30
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-27', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elective Caesarean Section', 'obese women', 'BMI≥30', 'spinal anesthesia combined with intrathecal morphine'], 'conditions': ['Respiratory Depression']}, 'descriptionModule': {'briefSummary': 'The study will examine whether there is a difference in the frequencies of respiratory depression among obese women receiving spinal anesthesia combined with opioids compared to women with normal BMI.\n\nIf such a risk exists further investigation will be required to establish the proper criteria for the administration of morphine with spinal anesthesia to obese women.', 'detailedDescription': 'Since 1979, intrathecal morphine combined with spinal anesthesia has been shown to provide effective postoperative analgesia in a variety of surgeries and more specifically in caesarean sections.\n\nThe advantages of addition of morphine to spinal analgesia are in prolonged analgesia during the operation and post operatively. In addition the analgesia is provided using a single injection during the time of surgery with no further need for complex and costly instruments like an opioid pump .\n\nThe side effects and risks of intrathecal morphine include: nausea, vomiting, pruritus urinary retention and the most severe being respiratory depression (immediate or delayed). The mild side effects were higher postoperatively in patients receiving spinal anesthesia combined with morphine. In a meta-analysis study of different surgeries performed under spinal anesthesia, it has been shown that at low doses (\\<0.3mg) intrathecal morphine does not increase the rate of respiratory depression. Nonetheless higher doses (\\>0.3mg) were associated with more incidents of respiratory depression. In another study there was no evidence of respiratory depression following caesarean section under spinal anesthesia combined with morphine. Yet, in a prospective study that reviewed 856 cases of caesarean sections under spinal anesthesia combined with morphine a rate of 8 incidences of respiratory depression were found. In a retrospective study of 1915 cases of women undergoing caesarean section with spinal anesthesia combined with morphine a rate of 0.25% of respiratory depression was reported.\n\nThe definition of respiratory depression is the lack of response to hypercapnia and/or hypoxia and it has been shown that intrathecal morphine depresses both responses. The common parameters that are monitored in order to detect respiratory depression include respiratory rate, sedation score, pulse oximetry, high PCo2 levels and the need for naloxone treatment. However, the overall measurement of frequency of respiratory depression postoperatively is variable. Accounting for this variability is the fact that hypercapnia may occur in patients with normal respiratory rate, normal sedation score and normal oxygen saturation. In addition, respiratory depression detected by high levels of PCo2 may be recognized earlier than with other parameters.\n\nThe risk factors that were found to be associated with respiratory depression included high BMI, prior opioid use, magnesium infusion and respiratory comorbidities In a study of 856 women 8 of them experienced oxygen desaturation during sleep. All of these women were extremely obese with a prior history of deep snoring.\n\nIn this study the investigators would like to examine whether there is a difference in the frequency of episodes of respiratory depression between obese (BMI≥30) and women with normal BMI receiving spinal anesthesia combined with intrathecal morphine during elective caesarean section. In previous studies it was reported that obese and non-obese women do not respond differently to modest doses of spinal anesthesia. Hence in this study the investigators can be certain that the investigators are examining the influence of addition of morphine to the spinal anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy\n* Healthy women\n\nExclusion Criteria:\n\n* Heart diseases\n* Autoimmune diseases\n* Respiratory diseases'}, 'identificationModule': {'nctId': 'NCT02819661', 'briefTitle': 'Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Difference in the Frequency of Episodes of Respiratory Depression Between Obese (BMI≥30) and Women With Normal BMI Receiving Spinal Anesthesia Combined With Intrathecal Morphine During Elective Caesarean Section', 'orgStudyIdInfo': {'id': '0202-16-RMB CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'women BMI<30 POD 1', 'description': 'Pregnant healthy women with BMI\\<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.', 'interventionNames': ['Device: SOMNOTOUCH RESP', 'Procedure: Caesarean section', 'Drug: Spinal anesthesia with intrathecal morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women BMI≥30 POD 1', 'description': 'Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.', 'interventionNames': ['Device: SOMNOTOUCH RESP', 'Procedure: Caesarean section', 'Drug: Spinal anesthesia with intrathecal morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women BMI<30 POD4', 'description': 'Pregnant healthy women with BMI\\<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.', 'interventionNames': ['Device: SOMNOTOUCH RESP', 'Procedure: Caesarean section', 'Drug: Spinal anesthesia with intrathecal morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women BMI≥30 POD 4', 'description': 'Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.', 'interventionNames': ['Device: SOMNOTOUCH RESP', 'Procedure: Caesarean section', 'Drug: Spinal anesthesia with intrathecal morphine']}], 'interventions': [{'name': 'SOMNOTOUCH RESP', 'type': 'DEVICE', 'description': 'Ventilatory effort recorder', 'armGroupLabels': ['women BMI<30 POD 1', 'women BMI<30 POD4', 'women BMI≥30 POD 1', 'women BMI≥30 POD 4']}, {'name': 'Caesarean section', 'type': 'PROCEDURE', 'description': 'Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).', 'armGroupLabels': ['women BMI<30 POD 1', 'women BMI<30 POD4', 'women BMI≥30 POD 1', 'women BMI≥30 POD 4']}, {'name': 'Spinal anesthesia with intrathecal morphine', 'type': 'DRUG', 'otherNames': ['Subarachnoid block with intrathecal morphine', 'spinal block with intrathecal morphine'], 'description': 'is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space', 'armGroupLabels': ['women BMI<30 POD 1', 'women BMI<30 POD4', 'women BMI≥30 POD 1', 'women BMI≥30 POD 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'state': 'Isreal', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Rinat Lasker', 'role': 'CONTACT', 'email': 'r_laker@rmc.gov.il', 'phone': '+972-503312506'}], 'facility': 'Rambam healthcare campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ronnie Klein', 'role': 'CONTACT', 'email': 'ronnie@ir-medical.com', 'phone': '+972-586972-195'}, {'name': 'Yaniv Cohen', 'role': 'CONTACT', 'email': 'yaniv@ir-medical.com', 'phone': '+972-52-4677841'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}