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

The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Induction; Hemodynamic Stability; Electro-acupuncture; Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Other: electrical acupoint stimulation

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhihong Lu; Phone Number: 86-13891975018; Email: deerlu23@163.com
• Study Contact Backup: Name: Hailong Dong; Phone Number: 86-29-84775337; Email: hldong6@hotmail.com

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Recruiting
      • Xijing Hospital, Fourth Military Medical University
      • Contact: Zhihong Lu, Doctor; Phone Number: 86-29-84775343; Email: deerlu23@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-frequency; The electrical stimulation is provided at a frequency of 100Hz	Other: electrical acupoint stimulation; Electrical stimulation are administered at Neiguan, Jian Shi, and Baihui. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.
Active Comparator: Low-frequency; The electrical stimulation is provided at a frequency of 2Hz	Other: electrical acupoint stimulation; Electrical stimulation are administered at Neiguan, Jian Shi, and Baihui. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.	The MAP is continuously recorded by the DoCare Information System every 30 seconds. The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX), where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5, …, 15) after start of anesthesia induction, and ΔX is the time interval between measurements.	from start of induction to 15 minutes after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension during the induction period		from start of induction to 15 minutes after induction
The dosage of vasoactive drugs		from start of induction to 15 minutes after induction
The incidence of major complications (cardiovascular adverse events, acute kidney injury, delirium)		from end of surgery to discharge from the hospital, at an average of 5 days
Length of hospital stay		from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients admitted to the intensive care unit (ICU) after surgery		from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients achieving the best recovery after surgery (discharged within 5 days after surgery, without major complications, no incision infection, no readmission, and survive within 30 days after surgery)		from end of surgery to 30 days after surgery
The score of the discharge quality assessment scale	Quality of Recovery, QoR-15 15 items across 5 dimensions: physical comfort, physical independence, psychological support, emotional state, and pain. Each item is scored from 0 to 10. The total score ranges from 0 to 150, with a higher score representing better recovery. A change of 8 points or more is considered a Minimally Clinically Important Difference (MCID), meaning a meaningful improvement or decline from the patient's perspective.	at discharge from the hospital, at an average of 5 days after surgery

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: XJH-A-20251111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No