Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163990
• Other study ID #: XJTU1AF2021LSK-332
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Other:
• transcutaneous acupoint electrical stimulation
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Cae — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	usage of ephedrine	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
Secondary	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
Secondary	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