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

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous Electrical Acupoint Stimulation
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Betul Kozanhan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

GROUP TEAS

Sham TEAS

Arm Description

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.

In the sham TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation.

Outcomes

Primary Outcome Measures

patients blood pressure will be measured
Hypotension was defined as a preoperative systolic measurement of >20% or a systolic blood pressure below 100 mmHg.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2022
Last Updated
September 16, 2022
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05272033
Brief Title
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly
Official Title
The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP TEAS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham TEAS
Arm Type
Sham Comparator
Arm Description
In the sham TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Acupoint Stimulation
Intervention Description
Transcutaneous Electrical Acupoint Stimulation
Primary Outcome Measure Information:
Title
patients blood pressure will be measured
Description
Hypotension was defined as a preoperative systolic measurement of >20% or a systolic blood pressure below 100 mmHg.
Time Frame
30 minutes following spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Betul Kozanhan
City
Konya
ZIP/Postal Code
42005
Country
Turkey

12. IPD Sharing Statement

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

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