Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03508102
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2017-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058926', 'term': 'Intraoperative Awareness'}], 'ancestors': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-15', 'studyFirstSubmitDate': '2017-11-29', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.', 'timeFrame': 'the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery', 'description': 'the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery'}], 'secondaryOutcomes': [{'measure': 'incidence of intraoperative awareness', 'timeFrame': 'one day and one week after delivery.', 'description': 'the maternal incidence of intraoperative awareness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['remifentanil', 'bispectral index', 'Caesarean delivery', 'general anesthesia'], 'conditions': ['Intraoperative Awareness']}, 'descriptionModule': {'briefSummary': 'Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.', 'detailedDescription': 'Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia\n\nExclusion Criteria:\n\n* multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication'}, 'identificationModule': {'nctId': 'NCT03508102', 'briefTitle': 'Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'West China Second University Hospital'}, 'officialTitle': 'Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia', 'orgStudyIdInfo': {'id': '2015001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remifentanil 1 μg kg-1 (R1)', 'description': 'Received remifentanil 1μg/kg when induction of general anesthesia', 'interventionNames': ['Drug: remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Remifentanil 0.5 μg kg-1 (R0.5),', 'description': 'Received remifentanil 0.5μg/kg when induction of general anesthesia', 'interventionNames': ['Drug: remifentanil']}, {'type': 'NO_INTERVENTION', 'label': 'saline (control)', 'description': 'Injected the equal volume normal saline when induction of general anesthesia'}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'the effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery', 'armGroupLabels': ['Remifentanil 0.5 μg kg-1 (R0.5),', 'Remifentanil 1 μg kg-1 (R1)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Second University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'Qing Zhu', 'investigatorAffiliation': 'West China Second University Hospital'}}}}