Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAir Force Military Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age of the patients is 60 years or older;

Patients who are scheduled to undergo TAVR surgery under general anesthesia;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • electrical acupoint stimulation

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: High-frequencyExperimental treatment 1 intervention
Group B: Low-frequencyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
from start of induction to 15 minutes after induction

Secondary outcomes

1

Incidence of hypotension during the induction period

Time frame
from start of induction to 15 minutes after induction
2

The dosage of vasoactive drugs

Time frame
from start of induction to 15 minutes after induction
3

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
4

Length of hospital stay

Time frame
from end of surgery to discharge from the hospital, at an average of 5 days

Other outcomes

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