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

Xi'an Jiaotong University

Status: Completed

Conditions: Hypotension

Treatments: Other: transcutaneous acupoint electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05163990

XJTU1AF2021LSK-332

Details and patient eligibility

About

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

Full 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).

Enrollment: 64 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

TEAS group

Experimental group

Description:

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.

Treatment:

Other: transcutaneous acupoint electrical stimulation

Control group

No Intervention group

Description:

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.