Effect of TEAS on PONV After Spinal Surgery

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jyoti Pandya
Study ID
NCT03187535
Status
Recruiting
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Conditions

  • PONV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TEAS via ES-130 — DEVICE
    Transcutaneous Electrical Acupoint Stimulation will be administered delivered by the ES-130 device for 20 minutes at the time ondansetron is given (typically 30 minutes before the end of surgery). Subjects randomized to this intervention will have the TEAS device connected to the previously placed ECG patches to deliver the stimulus.
  • No TEAS — OTHER
    No Transcutaneous Electrical Acupoint Stimulation will be delivered to the subjects randomized to this group; ECG patches will be placed at the identified acupoints, however, no electrical stimulus will be delivered.

Study Details

The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.

Key Dates

Start date
Aug 1, 2018
Status verified
Mar 2025
Primary completion
Nov 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Transcutaneous Electrical Acupoint Stimulation
    Subjects in the "Transcutaneous Electrical Acupoint Stimulation" (TEAS) group will receive 20 minutes of TEAS via ES-130 beginning at the time ondansetron is administered (usually given 30 minutes before the end of surgery), for prevention of PONV.
  • Sham Comparator: No Transcutaneous Electrical Acupoint Stimulation
    Subjects in the "No Transcutaneous Electrical Acupoint Stimulation" group will not receive any TEAS, although they will have the acupoints identified and ECG patches placed. The device will not be connected to the electrodes of the ES-130 device at the end of surgery, and no TEAS will be delivered.

Primary Outcome Measure

incidence of PONV [ Time Frame: up to 24 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Sergio D Bergese, MD
[email protected]
614.293.3559
Juan Fiorda, MD
[email protected]
614-293-3559

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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