Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients (FRESH-T)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Anesthesia Induction; Transcatheter Aortic Valve Replacement (TAVR); Electro-acupuncture; Hemodynamic Stability

Treatments: Other: electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07365345

XJH-A-20251111

Details and patient eligibility

About

Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.

Enrollment: 150 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The age of the patients is 60 years or older;
• Patients who are scheduled to undergo TAVR surgery under general anesthesia;

Exclusion criteria

• Body mass index less than 18 kg/m2 or greater than 30 kg/m2;
• Hemodynamic instability (severe arrhythmia, decompensated heart failure);
• Hypotension after admission requiring intervention with vasoactive drugs;
• Severe liver or kidney dysfunction;
• Those who are contraindicated for electrical stimulation, including those with local skin damage, infection, or having implanted electrophysiological devices in the body.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

High-frequency

Experimental group

Description:

The electrical stimulation is provided at a frequency of 100Hz

Treatment:

Other: electrical acupoint stimulation

Low-frequency

Active Comparator group

Description:

The electrical stimulation is provided at a frequency of 2Hz

Treatment:

Other: electrical acupoint stimulation