Anesthesia Induction, Electro-acupuncture, Hemodynamic Stability, Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Brief 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.
Interventions
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTZhihong Lu
CONTACTHailong Dong
Outcome results
None listed