Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension (EARTH)

Zhihong LU

Status: Completed

Conditions: Hypotension During Surgery

Treatments: Other: electrodes attached; Other: low frequency acupoint stimulation; Other: high frequency acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05724095

XJH-20230203

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years
• American Society of Anesthesiologists physical status Ⅰ-Ⅱ
• singleton pregnancy
• full-term gestation (≥38 weeks)

Exclusion criteria

• Parturients suffering from preeclampsia
• Parturients with hypertension, diabetes, or cardiac dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

control

Sham Comparator group

Treatment:

Other: electrodes attached

low frequency stimulation

Experimental group

Treatment:

Other: low frequency acupoint stimulation

Other: electrodes attached

high frequency stimulation

Experimental group

Treatment:

Other: high frequency acupoint stimulation

Other: electrodes attached