NCT05272033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

February 28, 2022

Last Update Submit

September 16, 2022

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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.

Device: Transcutaneous Electrical Acupoint Stimulation

Interventions

Transcutaneous Electrical Acupoint StimulationDEVICE

Transcutaneous Electrical Acupoint Stimulation

GROUP TEASSham TEAS

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

April 19, 2022

Primary Completion

September 16, 2022

Study Completion

September 16, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations

TU(1)