Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-28 @ 7:58 PM
Study NCT ID:
NCT05935657
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2023-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-04', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'Intraoperative period', 'description': 'mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline'}], 'secondaryOutcomes': [{'measure': 'Incidence of intraoperative bradycardia', 'timeFrame': 'Intraoperative period', 'description': 'heart rate lower than 45 bpm'}, {'measure': 'Incidence of intraoperative hypertension', 'timeFrame': 'Intraoperative period', 'description': 'mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline'}, {'measure': 'Incidence of respiratory depression', 'timeFrame': 'Intraoperative period', 'description': 'respiratory rate lower than 8 per minute'}, {'measure': 'Incidence of hypoxia', 'timeFrame': 'Intraoperative period', 'description': 'oxygen saturation detected by pulse oxymetry less than 93%'}, {'measure': 'Intraoperative Ramsay sedation scale', 'timeFrame': 'Intraoperative period', 'description': 'score of 1\\~6'}, {'measure': 'Number of phenylephrine, ephedrine, atropine administered', 'timeFrame': 'Intraoperative period', 'description': 'number of administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Remimazolam', 'Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.', 'detailedDescription': "Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.\n\nIn the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).\n\nHowever, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)\n* Contraindications or allergy to dexmedetomidine or remimazolam administration\n* Emergency surgery\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05935657', 'briefTitle': 'The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia', 'orgStudyIdInfo': {'id': '20230608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam Group', 'description': 'sedation with remimazolam', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group', 'description': 'sedation with dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['Byfavo'], 'description': '0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\\~1.0 mg/kg/h continuous infusion', 'armGroupLabels': ['Remimazolam Group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': '1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\\~0.7 mcg/kg/h continuous infusion', 'armGroupLabels': ['Dexmedetomidine group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jieun Jung, MD', 'role': 'CONTACT', 'email': 'jungje0308@gmail.com', 'phone': '820553602129'}], 'overallOfficials': [{'name': 'Gyengjo Byeon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor for fund', 'investigatorFullName': 'Gyeong-Jo Byeon, MD, PhD', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}