NCT07433218

Brief Summary

Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress28%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

February 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

AnesthesiaHypotension

Keywords

transcutaneous electrical acupoint stimulationfrequencyhemodynamic stability

Outcome Measures

Primary Outcomes (1)

  • incidence of hypotension

    Hypotension is defined as a Mean arterial pressure (MAP) reduction of more than 20% from baseline or a MAP less than 65 mm Hg for at least 1 minute. The baseline MAP is measured during the 5 minutes before start of intervention

    from start of anesthesia induction to 15 minutes after induction

Secondary Outcomes (5)

  • 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 dosage of vasoactive drugs

    from start of induction to 15 minutes after induction

  • lowest MAP

    from start of induction to 15 minutes after induction

  • standard deviation of R-R intervals (SDRR)

    from start of induction to 15 minutes after induction

  • ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)

    from start of induction to 15 minutes after induction

Study Arms (3)

High-frequency

EXPERIMENTAL

The electrical stimulation is provided at a frequency of 100Hz

Other: electrical acupoint stimulationOther: electrodes pastedOther: high-frequency electrical stimulation

Low-frequency

EXPERIMENTAL

The electrical stimulation is provided at a frequency of 2Hz

Other: electrical acupoint stimulationOther: electrodes pastedOther: low-frequency electrical stimulation

No stimulation

SHAM COMPARATOR

Only electrodes are pasted

Other: electrodes pasted

Interventions

electrical acupoint stimulationOTHER

electrical acupoint stimulation are administered at Neiguan and Jian Shi. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.

High-frequencyLow-frequency
electrodes pastedOTHER

Electrodes are pasted at Neiguan and Jianshi

High-frequencyLow-frequencyNo stimulation
high-frequency electrical stimulationOTHER

The frequency of electrical stimulation is 100Hz

High-frequency
low-frequency electrical stimulationOTHER

The frequency of electrical stimulation is 2Hz

Low-frequency

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged over 65 yrs old
  • scheduled for surgery under general anesthesia

You may not qualify if:

  • American society of anesthesiologists status over 3
  • severe cardiac or respiratory dysfunction
  • severe cardiac arrhythmia
  • uncontrolled diabetes
  • systolic arterial pressure over 180 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kaduk K, Petrella A, Muller SJ, Koenig J, Kroemer NB. Non-Invasive Auricular Vagus Nerve Stimulation Decreases Heart Rate Variability Independent of Caloric Load. Psychophysiology. 2025 Feb;62(2):e70017. doi: 10.1111/psyp.70017.

    PMID: 40007175BACKGROUND

  • Chaitman BR, Bitar SR. Is ST segment elevation non-Q-wave myocardial infarction after thrombolytic therapy a new clinical entity that requires an invasive management strategy? J Am Coll Cardiol. 2001 Jan;37(1):26-9. doi: 10.1016/s0735-1097(00)01053-6. No abstract available.

    PMID: 11153749BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018deerlu23@163.com

Study Design

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

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 25, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The de-identified data will be available with reasonable request from Dr. Zhihong Lu at deerlu23@163.com

Shared Documents
STUDY PROTOCOL
Time Frame
after publication
Access Criteria
with request to Dr. Zhihong Lu