NCT07365345

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 30, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 25, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 30, 2025

Last Update Submit

March 22, 2026

Conditions

Transcatheter Aortic Valve Replacement (TAVR)Hemodynamic StabilityElectro-acupunctureAnesthesia Induction

Outcome Measures

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.

    from start of induction to 15 minutes after induction

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

High-frequency

EXPERIMENTAL

The electrical stimulation is provided at a frequency of 100Hz

Other: electrical acupoint stimulation

Low-frequency

ACTIVE COMPARATOR

The electrical stimulation is provided at a frequency of 2Hz

Other: electrical acupoint stimulation

Interventions

electrical acupoint stimulationOTHER

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.

High-frequencyLow-frequency

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age of the patients is 60 years or older;
  • Patients who are scheduled to undergo TAVR surgery under general anesthesia;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shannxi, 710032, China

RECRUITING

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018deerlu23@163.com

Hailong Dong

CONTACT

86-29-84775337hldong6@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 26, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 25, 2026

Record last verified: 2026-01

Locations

CN(1)