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The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.
After being informed about the study and potential risks, all patients giving written informed consent will undergo the doctors' and researchers' examination to determine eligibility for study entry. At beginning of the study, patients who meet the eligibility requirements will be randomized in a open manner(participant and electroacupuncture executor)in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration) or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAS group | Experimental | 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration. |
|
| Control group | No Intervention | Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous acupoint electrical stimulation | Other | The corresponding transcutaneous acupoint electrical stimulation is given to different groups before spinal anesthesia, which last from 10 minutes before anesthesia to 30 minutes after subarachnoid administration. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hypotension | the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration |
| Measure | Description | Time Frame |
|---|---|---|
| specific changes of hemodynamic indexes | compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable. | within 30 minutes after subarachnoid administration |
| usage of ephedrine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang, doctor | First Affiliated Hospital of Xian Jiaotong University | Study Chair |
| Ying Xiao, doctor | First Affiliated Hospital of Xian Jiaotong University | Study Director |
| Juan Bai, doctor | First Affiliated Hospital of Xian Jiaotong University | Study Director |
| Meng Yue Xu, postgraduate | Shaanxi University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17959591 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2021 | Dec 4, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2021 | Dec 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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TEAS group: 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration.
Control group: Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.
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the usage of ephedrine within 30 minutes after subarachnoid administration in TEAS group was significantly less than that in Control group.
| within 30 minutes after subarachnoid administration |
| incidence of nausea and vomiting | the incidence of nausea and vomiting within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration |
| incidence of dizziness, chest tightness and dyspnea | the incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration |