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

September 11, 2026 updated by: Zhihong LU

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

From 15 minutes before to 15 minutes after anesthesia, Transcutaneous Electrical Acupoint Stimulation(TEAS) at different frequencies will be applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period will be compared among the high-frequency group ,the low-frequency group and the control group to explore the better frequency to reduce the incidence of post-induction hypotension(PIH) in the elderly.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged over 65 yrs old
  • elective abdominal surgery under general anesthesia
  • written infromed consent

Exclusion Criteria:

  • American society of anesthesiologists status over 3
  • New York Heart Association (NYHA) Functional Classification≥Ⅲ
  • severe arrhythmia leading to hemodynamic instability
  • uncontrolled diabetes
  • hypertension patients stratified as very high risk according to cardiovascular risk classification
  • people who have TEAS contraindications such as local acupoint skin injury or infection and implanted cardiac pacemaker

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
Intervention / Treatment
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

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 30 seconds.

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

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
major in-hospital complication incidence within 5 postoperative days
Time Frame: from start of anesthesia to the 5 days after anesthesia
major in-hospital complication incidence within 5 postoperative days
from start of anesthesia to the 5 days after anesthesia

Collaborators and Investigators

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

Sponsor

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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