NCT03187535 Effect of TEAS on PONV After Spinal Surgery
| NCT ID | NCT03187535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jyoti Pandya |
| Condition | PONV |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2018-08-01 |
| Primary Completion | 2027-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2018-08-01 with a primary completion date of 2027-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Sergio Bergese, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT03187535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PONV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03187535 currently recruiting?
Yes, NCT03187535 is actively recruiting participants. Contact the research team at juan.fiorda@osumc.edu for enrollment information.
Where is the NCT03187535 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT03187535 clinical trial?
NCT03187535 is sponsored by Jyoti Pandya. The principal investigator is Sergio Bergese, MD at Ohio State University. The trial plans to enroll 72 participants.