The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
| Registry | NCT07365345, acronym FRESH-T |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Air Force Military Medical University, China (Other) |
| Conditions | Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture |
| Interventions | electrical acupoint stimulation (Other) |
| Dates | start 2026-01-30, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-01-26, last updated 2026-03-25 |
| Locations | 1 site in China |
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-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| High-frequency | Experimental | Other: electrical acupoint stimulation | The electrical stimulation is provided at a frequency of 100Hz |
| Low-frequency | Active comparator | Other: electrical acupoint stimulation | The electrical stimulation is provided at a frequency of 2Hz |
- electrical acupoint stimulation (Other): 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.
+Outcome measures
Primary outcomes
- The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline. [from start of induction to 15 minutes after induction]: 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.
Secondary outcomes
- 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 [at discharge from the hospital, at an average of 5 days after surgery]: 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.
+Eligibility
Sex: All, ages: 60 Years to any
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Xijing Hospital, Fourth Military Medical University | Xi'an, Shannxi | China | Recruiting |