What this study is
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.
What's being tested
- TEAS via ES-130
Intervention · 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
Intervention · 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
- Official title
- The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
- Sponsor
- Jyoti Pandya
- Conditions
- PONV
- Enrolling
- 72 people
- Starts
- 2018-08-01
- Est. completion
- 2027-12-20
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- Sergio D Bergese, MD · Contact614.293.3559Sergio.Bergese@osumc.edu
- Juan Fiorda, MD · Contact614-293-3559juan.fiorda@osumc.edu
Recruiting
Study team
Sponsor
Jyoti Pandya
Study ID 2017H0101
Principal investigator
Sergio Bergese, MD
Ohio State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.