Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT05789992
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-24', 'releaseDate': '2024-07-26'}], 'estimatedResultsFirstSubmitDate': '2024-07-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction probability of eMAC', 'timeFrame': '1 year', 'description': 'Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated.'}], 'secondaryOutcomes': [{'measure': 'Prediction probability of BIS', 'timeFrame': '1 year', 'description': 'Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween BIS and the lable of response was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '20216387', 'type': 'BACKGROUND', 'citation': 'Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.'}, {'pmid': '23471754', 'type': 'BACKGROUND', 'citation': 'Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.'}, {'pmid': '19741484', 'type': 'BACKGROUND', 'citation': 'Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.'}], 'seeAlsoLinks': [{'url': 'https://pubs.asahq.org/anesthesiology/article/112/4/872/10694/Noxious-Stimulation-Response-IndexA-Novel', 'label': 'For PubMed ID: 20216387'}, {'url': 'https://pubs.asahq.org/anesthesiology/article/111/4/790/9625/Response-Surface-Modeling-of-the-Interaction', 'label': 'For PubMed ID: 19741484'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.', 'detailedDescription': "eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.\n\nPatients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing elective surgery under general anesthesia;\n2. Patients with ASA rating I\\~III;\n3. The age of the patient is more than 18 years old;\n4. The informed consent has been signed;\n\nExclusion Criteria:\n\n1. Patients who are participating in other trials;\n2. Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;\n3. Patients with a history of stroke;\n4. Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);\n5. Pregnant women;\n6. Patients with BMI\\>30;\n7. Patients and family members who are unwilling to participate after understanding the research content;\n8. According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.'}, 'identificationModule': {'nctId': 'NCT05789992', 'acronym': 'eMAC', 'briefTitle': 'Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations', 'orgStudyIdInfo': {'id': '202302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 BIS under tetanic electrical stimulation', 'description': "During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.", 'interventionNames': ['Drug: Propofol', 'Drug: Low Remifentanil', 'Procedure: tetanic electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 eMAC under tetanic electrical stimulation', 'description': "During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.", 'interventionNames': ['Drug: Propofol', 'Drug: Low Remifentanil', 'Procedure: tetanic electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 BIS under intubation', 'description': "During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.", 'interventionNames': ['Drug: Propofol', 'Drug: Heigh Remifentanil', 'Procedure: Intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4 eMAC under intubation', 'description': "During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.", 'interventionNames': ['Drug: Propofol', 'Drug: Heigh Remifentanil', 'Procedure: Intubation']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol for tetanic electrical stimulation and intubation'], 'description': 'Propofol (Random:3-5ug/ml)', 'armGroupLabels': ['Group 1 BIS under tetanic electrical stimulation', 'Group 2 eMAC under tetanic electrical stimulation', 'Group 3 BIS under intubation', 'Group 4 eMAC under intubation']}, {'name': 'Low Remifentanil', 'type': 'DRUG', 'otherNames': ['Remifentanil for tetanic electrical stimulation'], 'description': 'Remifentanil (Random:0-3ug/ml)', 'armGroupLabels': ['Group 1 BIS under tetanic electrical stimulation', 'Group 2 eMAC under tetanic electrical stimulation']}, {'name': 'Heigh Remifentanil', 'type': 'DRUG', 'otherNames': ['Remifentanil for intubation'], 'description': 'Remifentanil (Random:3-5ug/ml)', 'armGroupLabels': ['Group 3 BIS under intubation', 'Group 4 eMAC under intubation']}, {'name': 'Intubation', 'type': 'PROCEDURE', 'description': 'Endotracheal intubation before surgery', 'armGroupLabels': ['Group 3 BIS under intubation', 'Group 4 eMAC under intubation']}, {'name': 'tetanic electrical stimulation', 'type': 'PROCEDURE', 'description': 'tetanic electrical stimulation before surgery', 'armGroupLabels': ['Group 1 BIS under tetanic electrical stimulation', 'Group 2 eMAC under tetanic electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Haopeng Zhang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhang Haopeng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zhang Haopeng', 'investigatorAffiliation': 'Xijing Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-26', 'type': 'RELEASE'}, {'date': '2024-10-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zhang Haopeng, Associate professor, Xijing Hospital'}}}}