AnesthesiaFRESHNCT07433218
Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
A study testing electrical acupoint stimulation, electrodes pasted and high-frequency electrical stimulation in people with Anesthesia and Post-induction Hypotension (PIH), run by Zhihong LU.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia, Post-induction Hypotension (PIH), Transcutaneous Electrical Acupoint Stimulation
- What is being tested?
- electrical acupoint stimulation, electrodes pasted and high-frequency electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged over 65 yrs old
- elective abdominal surgery under general anesthesia
- written infromed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Anesthesia, Post-induction Hypotension (PIH), Transcutaneous Electrical Acupoint Stimulation
- Being tested
- electrical acupoint stimulation, electrodes pasted, high-frequency electrical stimulation, low-frequency electrical stimulation
- Keywords
- transcutaneous electrical acupoint stimulation, frequency, hemodynamic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
electrodes pastedOther
Electrodes are pasted at Neiguan and Jianshi
high-frequency electrical stimulationOther
The frequency of electrical stimulation is 100Hz
low-frequency electrical stimulationOther
The frequency of electrical stimulation is 2Hz
| Study group | Role | What they receive |
|---|---|---|
| High-frequency | Experimental | The electrical stimulation is provided at a frequency of 100Hz Receives: Other: electrical acupoint stimulation; Other: electrodes pasted; Other: high-frequency electrical stimulation |
| Low-frequency | Experimental | The electrical stimulation is provided at a frequency of 2Hz Receives: Other: electrical acupoint stimulation; Other: electrodes pasted; Other: low-frequency electrical stimulation |
| No stimulation | Sham comparator | Only electrodes are pasted Receives: Other: electrodes pasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 30 seconds.
The baseline MAP is measured during the 5 minutes before start of intervention
Measured: from start of anesthesia induction to 15 minutes after induction
Secondary outcomes (6)
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
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.
Measured: from start of induction to 15 minutes after induction
The dosage of vasoactive drugs
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.
Measured: from start of induction to 15 minutes after induction
lowest MAP
Measured: from start of induction to 15 minutes after induction
standard deviation of R-R intervals (SDRR)
assessed from the electrocardiography, key index of heart rate variability (HRV)
Measured: from start of induction to 15 minutes after induction
ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)
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
Measured: from start of induction to 15 minutes after induction
major in-hospital complication incidence within 5 postoperative days
major in-hospital complication incidence within 5 postoperative days
Measured: from start of anesthesia to the 5 days after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433218
- Sponsor's protocol ID
- XJH-A-20260220
- Acronym
- FRESH
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data will be available with reasonable request from Dr. Zhihong Lu at deerlu23@163.com
Publications
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.
PubMed 40007175Chaitman 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.
PubMed 11153749
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT07433218
- Acronym / sponsor ID
- FRESH / XJH-A-20260220
- Conditions
- Anesthesia, Post-induction Hypotension (PIH), Transcutaneous Electrical Acupoint Stimulation
- Keywords
- transcutaneous electrical acupoint stimulation, frequency, hemodynamic stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency | Experimental | Other: electrical acupoint stimulation, Other: electrodes pasted, Other: high-frequency electrical stimulationThe electrical stimulation is provided at a frequency of 100Hz |
| Low-frequency | Experimental | Other: electrical acupoint stimulation, Other: electrodes pasted, Other: low-frequency electrical stimulationThe electrical stimulation is provided at a frequency of 2Hz |
| No stimulation | Sham comparator | Other: electrodes pastedOnly electrodes are pasted |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged over 65 yrs old
- elective abdominal surgery under general anesthesia
- written infromed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical acupoint stimulationelectrical 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 | High-frequency, Low-frequency |
| electrodes pastedElectrodes are pasted at Neiguan and Jianshi | Other | High-frequency, Low-frequency, No stimulation |
| high-frequency electrical stimulationThe frequency of electrical stimulation is 100Hz | Other | High-frequency |
| low-frequency electrical stimulationThe frequency of electrical stimulation is 2Hz | Other | Low-frequency |
Primary outcome
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
6 secondary outcomes
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 dosage of vasoactive drugs
Time frame: from start of induction to 15 minutes after induction
lowest MAP
Time frame: 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
ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 40007175Kaduk 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.
- Background: PubMed 11153749Chaitman 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.
- Individual participant dataSharing planned: Yes. The de-identified data will be available with reasonable request from Dr. Zhihong Lu at deerlu23@163.com
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing electrical acupoint stimulation, electrodes pasted and high-frequency electrical stimulation in people with Anesthesia and Post-induction Hypotension (PIH), run by Zhihong LU.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (86-13891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypotension (time frame: from start of anesthesia induction to 15 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433218, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.