Frequency of Electrical Acupoint Stimulation on Hypotension During Induction (FRESH)

February 20, 2026 updated by: Zhihong LU

The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-frequency
The electrical stimulation is provided at a frequency of 100Hz
Other: electrical acupoint stimulation
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.
Other: electrodes pasted
Electrodes are pasted at Neiguan and Jianshi
Other: high-frequency electrical stimulation
The frequency of electrical stimulation is 100Hz
Experimental: Low-frequency
The electrical stimulation is provided at a frequency of 2Hz
Other: electrical acupoint stimulation
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.
Other: electrodes pasted
Electrodes are pasted at Neiguan and Jianshi
Other: low-frequency electrical stimulation
The frequency of electrical stimulation is 2Hz
Sham Comparator: No stimulation
Only electrodes are pasted
Other: electrodes pasted
Electrodes are pasted at Neiguan and Jianshi

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of hypotension
Time Frame: from start of anesthesia induction to 15 minutes after induction

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The area under the curve (AUC) below baseline mean arterial pressure (MAP) is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at the i-th minute (i = 1…15), and ΔX is the time interval between two measurements.
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
Any MAP drop by more than 20% from baseline or a MAP less than 65 mm Hg for at least 1 minute within the first 15 minutes after general anesthesia induction triggered the administration of norepinephrine boluses (5 μg). If hypotension persisted after 2 boluses, a norepinephrine infusion (0.02-0.3 μg/kg/min) was initiated and continued until the MAP became stable and reached 65 mm Hg or higher. If hypotension reoccurred, 2 boluses of norepinephrine were repeated.
from start of induction to 15 minutes after induction
lowest MAP
Time Frame: from start of induction to 15 minutes after induction
from start of induction to 15 minutes after induction
standard deviation of R-R intervals (SDRR)
Time Frame: from start of induction to 15 minutes after induction
assessed from the electrocardiography, key index of heart rate variability (HRV)
from start of induction to 15 minutes after induction
ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)
Time Frame: from start of induction to 15 minutes after induction
assessed from the electrocardiography,High-frequency HRV (HF-HRV) at 0.15-0.4 Hz and low-frequency HRV (LF-HRV) at 0.04-0.15 Hz
from start of induction to 15 minutes after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhihong LU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJH-A-20260220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

after publication

IPD Sharing Access Criteria

with request to Dr. Zhihong Lu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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