Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-10 @ 2:16 AM
Study NCT ID:
NCT07433218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypotension', 'timeFrame': 'from start of anesthesia induction to 15 minutes after induction', 'description': 'Hypotension is defined as a Mean arterial pressure (MAP) reduction of more than 20% from baseline or a MAP less than 65 mm Hg for at least 1 minute.\n\nThe baseline MAP is measured during the 5 minutes before start of intervention'}], 'secondaryOutcomes': [{'measure': 'The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.', 'timeFrame': 'from start of induction to 15 minutes after induction', 'description': 'The area under the curve (AUC) below baseline mean arterial pressure (MAP) is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at the i-th minute (i = 1…15), and ΔX is the time interval between two measurements.'}, {'measure': 'The dosage of vasoactive drugs', 'timeFrame': 'from start of induction to 15 minutes after induction', 'description': 'Any MAP drop by more than 20% from baseline or a MAP less than 65 mm Hg for at least 1 minute within the first 15 minutes after general anesthesia induction triggered the administration of norepinephrine boluses (5 μg). If hypotension persisted after 2 boluses, a norepinephrine infusion (0.02-0.3 μg/kg/min) was initiated and continued until the MAP became stable and reached 65 mm Hg or higher. If hypotension reoccurred, 2 boluses of norepinephrine were repeated.'}, {'measure': 'lowest MAP', 'timeFrame': 'from start of induction to 15 minutes after induction'}, {'measure': 'standard deviation of R-R intervals (SDRR)', 'timeFrame': 'from start of induction to 15 minutes after induction', 'description': 'assessed from the electrocardiography, key index of heart rate variability (HRV)'}, {'measure': 'ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)', 'timeFrame': 'from start of induction to 15 minutes after induction', 'description': 'assessed from the electrocardiography,High-frequency HRV (HF-HRV) at 0.15-0.4 Hz and low-frequency HRV (LF-HRV) at 0.04-0.15 Hz'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical acupoint stimulation', 'frequency', 'hemodynamic stability'], 'conditions': ['Anesthesia', 'Hypotension']}, 'referencesModule': {'references': [{'pmid': '40007175', 'type': 'BACKGROUND', 'citation': 'Kaduk K, Petrella A, Muller SJ, Koenig J, Kroemer NB. Non-Invasive Auricular Vagus Nerve Stimulation Decreases Heart Rate Variability Independent of Caloric Load. Psychophysiology. 2025 Feb;62(2):e70017. doi: 10.1111/psyp.70017.'}, {'pmid': '11153749', 'type': 'BACKGROUND', 'citation': 'Chaitman BR, Bitar SR. Is ST segment elevation non-Q-wave myocardial infarction after thrombolytic therapy a new clinical entity that requires an invasive management strategy? J Am Coll Cardiol. 2001 Jan;37(1):26-9. doi: 10.1016/s0735-1097(00)01053-6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged over 65 yrs old\n* scheduled for surgery under general anesthesia\n\nExclusion Criteria:\n\n* American society of anesthesiologists status over 3\n* severe cardiac or respiratory dysfunction\n* severe cardiac arrhythmia\n* uncontrolled diabetes\n* systolic arterial pressure over 180 mmHg'}, 'identificationModule': {'nctId': 'NCT07433218', 'acronym': 'FRESH', 'briefTitle': 'Frequency of Electrical Acupoint Stimulation on Hypotension During Induction', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction', 'orgStudyIdInfo': {'id': 'XJH-A-20260220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-frequency', 'description': 'The electrical stimulation is provided at a frequency of 100Hz', 'interventionNames': ['Other: electrical acupoint stimulation', 'Other: electrodes pasted', 'Other: high-frequency electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Low-frequency', 'description': 'The electrical stimulation is provided at a frequency of 2Hz', 'interventionNames': ['Other: electrical acupoint stimulation', 'Other: electrodes pasted', 'Other: low-frequency electrical stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'No stimulation', 'description': 'Only electrodes are pasted', 'interventionNames': ['Other: electrodes pasted']}], 'interventions': [{'name': 'electrical acupoint stimulation', 'type': 'OTHER', 'description': 'electrical acupoint stimulation are administered at Neiguan and Jian Shi. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.', 'armGroupLabels': ['High-frequency', 'Low-frequency']}, {'name': 'electrodes pasted', 'type': 'OTHER', 'description': 'Electrodes are pasted at Neiguan and Jianshi', 'armGroupLabels': ['High-frequency', 'Low-frequency', 'No stimulation']}, {'name': 'high-frequency electrical stimulation', 'type': 'OTHER', 'description': 'The frequency of electrical stimulation is 100Hz', 'armGroupLabels': ['High-frequency']}, {'name': 'low-frequency electrical stimulation', 'type': 'OTHER', 'description': 'The frequency of electrical stimulation is 2Hz', 'armGroupLabels': ['Low-frequency']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '86-13891975018'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after publication', 'ipdSharing': 'YES', 'description': 'The de-identified data will be available with reasonable request from Dr. Zhihong Lu at deerlu23@163.com', 'accessCriteria': 'with request to Dr. Zhihong Lu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}