Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
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- What is being studied
- The protocol lists: electrical acupoint stimulation.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xijing Hospital, Fourth Military Medical University — Xi'an
Identifiers
NCT: NCT07365345 · XJH-A-20251111