Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, 710032, China
Location status: Recruiting
Recruiting
NCT Number: NCT07365345
Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
60 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
electrical acupoint stimulation
OtherElectrical 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.
Primary outcomes
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The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
Time frame: 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
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Incidence of hypotension during the induction period
Time frame: from start of induction to 15 minutes after induction
-
The dosage of vasoactive drugs
Time frame: from start of induction to 15 minutes after induction
-
The incidence of major complications (cardiovascular adverse events, acute kidney injury, delirium)
Time frame: from end of surgery to discharge from the hospital, at an average of 5 days
-
Length of hospital stay
Time frame: 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
Time frame: 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)
Time frame: from end of surgery to 30 days after surgery
-
The score of the discharge quality assessment scale
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Hailong Dong
CONTACT
Zhihong Lu
CONTACT
Sponsors and collaborators
Lead sponsor
Air Force Military Medical University, China
Other
Registry information
Official study title
The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
Acronym: FRESH-T
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 26, 2026
- Registry last updated
- Mar 25, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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