Recruiting

TEAS

Sponsor:

Jyoti Pandya

Code:

NCT03187535

Conditions

PONV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TEAS via ES-130

No TEAS

Study Details

Brief 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

Study ID

NCT03187535

Start date

Aug 1, 2018

Status verified date

Jun, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Nov 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients , 18 or older
  • American Society of Anesthesiologists (ASA) classification I or II or III
  • Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation).
  • Capable and willing to consent

Exclusion Criteria:

  • Neuraxial (intrathecal or epidural) block
  • Significant ongoing history of vestibular disease or dizziness
  • Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery
  • Documented alcohol or substance abuse within 3 months before the surgery
  • Limb abnormalities such as burn and amputation.
  • Poorly controlled diabetes mellitus (fasting plasma glucose >126 mg/dL or <70 mg/dL)
  • Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids
  • Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area
  • Documented alcohol or substance abuse within 3 months before surgery
  • Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia
  • Chemotherapy or radiation therapy within 7 days before surgery
  • Investigational product use within 3 months prior surgery
  • Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures)
  • Special population (prisoners, pregnant and lactating women)

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Juan Fiorda, MD, PhD

614-293-3559juan.fiorda@osumc.edu

Alberto Uribe, MD

614-293-3559alberto.uribe@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Sergio D Bergese, MD

614.293.3559Sergio.Bergese@osumc.edu

Juan Fiorda, MD

614-293-3559juan.fiorda@osumc.edu

More Information

Sponsor

Jyoti Pandya

Last update posted

Jul 13, 2026

Last verified

Jun, 2026

Keywords

  • Transcutaneous Electrical Acupoint Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jyoti Pandya on 2026-07-13.