HypotensionNCT05272033
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Hypotension, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Transcutaneous Electrical Acupoint Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2022to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair
Who cannot join
- Patients with neurological or psychological diseases
- Patients who have been treated with TEAS or acupuncture before,
- Patients with heart failure and pace-maker
- Those who have a local infection in the TEAS area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients
Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal anesthesia in geriatric patients undergoing hernia surgery.
Read the detailed description
After obtaining written informed patient consent, 60 geriatric patients undergoing hernia surgery under spinal anesthesia were randomized into two groups. In the placebo TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. The acupoint group will receive TEAS at the PC-5, PC-6, and ST-36 points bilaterally before the spinal anesthesia. The spinal anesthesia will be performed using 12.5 mg 0.5% bupivacaine was from the L3-4 or L4-5 interval with a 25G Quincke spinal needle. Hemodynamic data will be followed every five minutes.
- Conditions
- Hypotension
- Being tested
- Transcutaneous Electrical Acupoint Stimulation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Acupoint StimulationDevice
Transcutaneous Electrical Acupoint Stimulation
| Study group | Role | What they receive |
|---|---|---|
| GROUP TEAS | Active comparator | Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at PC-5, PC-6, and ST-36 with an electronic acupuncture device. Receives: Device: Transcutaneous Electrical Acupoint Stimulation |
| Sham TEAS | Sham comparator | In the sham TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. Receives: Device: Transcutaneous Electrical Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients blood pressure will be measured
Hypotension was defined as a preoperative systolic measurement of >20% or a systolic blood pressure below 100 mmHg.
Measured: 30 minutes following spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start19 Apr 2022
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272033
- Sponsor's protocol ID
- TEAS Elderly Hypotension
- Status last verified
- Sep 2022
- First submitted
- 28 Feb 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT05272033
- Acronym / sponsor ID
- TEAS Elderly Hypotension
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 9 Mar 2022 (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.
Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal anesthesia in geriatric patients undergoing hernia surgery.
Detailed description
After obtaining written informed patient consent, 60 geriatric patients undergoing hernia surgery under spinal anesthesia were randomized into two groups. In the placebo TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. The acupoint group will receive TEAS at the PC-5, PC-6, and ST-36 points bilaterally before the spinal anesthesia. The spinal anesthesia will be performed using 12.5 mg 0.5% bupivacaine was from the L3-4 or L4-5 interval with a 25G Quincke spinal needle. Hemodynamic data will be followed every five minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP TEAS | Active comparator | Device: Transcutaneous Electrical Acupoint StimulationPatients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at PC-5, PC-6, and ST-36 with an electronic acupuncture device. |
| Sham TEAS | Sham comparator | Device: Transcutaneous Electrical Acupoint StimulationIn the sham TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair
Key exclusion criteria (4 listed)
- Patients with neurological or psychological diseases
- Patients who have been treated with TEAS or acupuncture before,
- Patients with heart failure and pace-maker
- Those who have a local infection in the TEAS area.
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 |
|---|---|---|
| Transcutaneous Electrical Acupoint StimulationTranscutaneous Electrical Acupoint Stimulation | Device | GROUP TEAS, Sham TEAS |
Primary outcome
patients blood pressure will be measured
Time frame: 30 minutes following spinal anesthesia
Hypotension was defined as a preoperative systolic measurement of >20% or a systolic blood pressure below 100 mmHg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Hypotension, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients blood pressure will be measured (time frame: 30 minutes following spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2022.