Clinical trial NCT05163990: Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia
Official title: Based on Non-invasive Cardiac Output Monitoring System to Explore the Preventive and Therapeutic Effect of Transcutaneous Acupoint Electrical Stimulation on Hypotension After Intraspinal Anesthesia in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18 years ≤ age \< 55 years
* ASA classification I \~ II
* full term (37 weeks ≤ gestational weeks \< 42 weeks)
* fchedule for elective single cesarean section under spinal anesthesia
* no other clinical trial 3 months before the enrollment
* volunteer to participate and sign the informed consent form

Exclusion Criteria:

* severe preeclampsia or hypertension
* diabetes
* cardiac insufficiency
* mental abnormality or cognitive impairment or inability to communicate
* acupuncture points skin breakage, infection, allergy
* the researchers believe that there are any conditions that are not suitable for inclusion.

Primary outcomes:
measure: incidence of hypotension
timeFrame: within 30 minutes after subarachnoid administration
Secondary outcomes:
measure: specific changes of hemodynamic indexes
timeFrame: within 30 minutes after subarachnoid administration
measure: usage of ephedrine
timeFrame: within 30 minutes after subarachnoid administration
measure: incidence of nausea and vomiting
timeFrame: within 30 minutes after subarachnoid administration
measure: incidence of dizziness, chest tightness and dyspnea
timeFrame: within 30 minutes after subarachnoid administration
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Qiang Wang, doctor
role: STUDY_CHAIR
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Ying Xiao, doctor
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Juan Bai, doctor
role: STUDY_DIRECTOR
affiliation: Shaanxi University of Chinese Medicine
name: Meng Yue Xu, postgraduate
role: PRINCIPAL_INVESTIGATOR
References:
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.