Effect of TEAS on PONV After Spinal Surgery
NCT03187535 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-03-24
Summary
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.
Conditions
- PONV
Interventions
- DEVICE
-
TEAS via ES-130
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.
- OTHER
-
No TEAS
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.
Sponsors & Collaborators
-
Jyoti Pandya
lead OTHER
Principal Investigators
-
Sergio Bergese, MD · Ohio State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2026-11-20
- Completion
- 2026-12-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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