Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-30 @ 9:19 AM
Study NCT ID:
NCT05724095
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2023-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-17', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypotension by 30 minutes after spinal anesthesia', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes', 'description': 'Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or \\<90 mm Hg'}], 'secondaryOutcomes': [{'measure': 'lowest systolic blood pressure during 30 minutes after spinal anesthesia', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes'}, {'measure': 'dose of ephedrine', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes', 'description': 'hypotension is treated with ephedrine in increments of 10 mg every 2 minutes'}, {'measure': 'nausea and vomiting score', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes', 'description': 'The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively.'}, {'measure': 'incidence of dizzy', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes'}, {'measure': 'incidence of apnea', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes'}, {'measure': 'incidence of chest congestion', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes'}, {'measure': 'dose of atropine', 'timeFrame': 'from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes', 'description': 'Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine'}, {'measure': 'Apgar score at 1 minute', 'timeFrame': '1minute after birth', 'description': 'Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical acupoint stimulation', 'spinal anesthesia', 'hypotension'], 'conditions': ['Hypotension During Surgery']}, 'referencesModule': {'references': [{'pmid': '17959591', 'type': 'RESULT', 'citation': 'Arai YC, Kato N, Matsura M, Ito H, Kandatsu N, Kurokawa S, Mizutani M, Shibata Y, Komatsu T. Transcutaneous electrical nerve stimulation at the PC-5 and PC-6 acupoints reduced the severity of hypotension after spinal anaesthesia in patients undergoing Caesarean section. Br J Anaesth. 2008 Jan;100(1):78-81. doi: 10.1093/bja/aem306. Epub 2007 Oct 24.'}, {'pmid': '20632667', 'type': 'RESULT', 'citation': 'Adigun TA, Amanor-Boadu SD, Soyannwo OA. Comparison of intravenous ephedrine with phenylephrine for the maintenance of arterial blood pressure during elective caesarean section under spinal anaesthesia. Afr J Med Med Sci. 2010 Mar;39(1):13-20.'}, {'pmid': '32619039', 'type': 'RESULT', 'citation': 'Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.'}, {'pmid': '38546428', 'type': 'DERIVED', 'citation': 'Liu X, Gao Z, Jiang Y, Tuo X, He S, Xu F, Lu Z. Comparison of Low-Frequency or High-Frequency Electrical Acupoint Stimulation on Hypotension After Spinal Anesthesia in Parturients: A Prospective Randomized Controlled Clinical Trial. J Integr Complement Med. 2024 Aug;30(8):770-775. doi: 10.1089/jicm.2023.0610. Epub 2024 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* American Society of Anesthesiologists physical status Ⅰ-Ⅱ\n* singleton pregnancy\n* full-term gestation (≥38 weeks)\n\nExclusion Criteria:\n\n* Parturients suffering from preeclampsia\n* Parturients with hypertension, diabetes, or cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT05724095', 'acronym': 'EARTH', 'briefTitle': 'Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'XJH-20230203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control', 'interventionNames': ['Other: electrodes attached']}, {'type': 'EXPERIMENTAL', 'label': 'low frequency stimulation', 'interventionNames': ['Other: low frequency acupoint stimulation', 'Other: electrodes attached']}, {'type': 'EXPERIMENTAL', 'label': 'high frequency stimulation', 'interventionNames': ['Other: high frequency acupoint stimulation', 'Other: electrodes attached']}], 'interventions': [{'name': 'high frequency acupoint stimulation', 'type': 'OTHER', 'description': 'electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given', 'armGroupLabels': ['high frequency stimulation']}, {'name': 'low frequency acupoint stimulation', 'type': 'OTHER', 'description': 'electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given', 'armGroupLabels': ['low frequency stimulation']}, {'name': 'electrodes attached', 'type': 'OTHER', 'description': 'electrodes are attached to area of acupoints', 'armGroupLabels': ['control', 'high frequency stimulation', 'low frequency stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing hospital, Fourth military medical university', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}