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NCT05272033 Clinical Trial

Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly

Hypotension Clinical Trial

Official title:
The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05272033
Other study ID # TEAS Elderly Hypotension
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2022
Est. completion date September 16, 2022

Study information
Verified date September 2022
Source Konya Meram State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 anesthesia in geriatric patients undergoing hernia surgery.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 16, 2022
Est. primary completion date September 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcutaneous Electrical Acupoint Stimulation
Transcutaneous Electrical Acupoint Stimulation

Locations
Country Name City State
Turkey Betul Kozanhan Konya

Sponsors (1)
Lead Sponsor Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary patients blood pressure will be measured Hypotension was defined as a preoperative systolic measurement of >20% or a systolic blood pressure below 100 mmHg. 30 minutes following spinal anesthesia
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