Effect of TEAS on PONV After Spinal Surgery



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:8/19/2018
Start Date:August 1, 2018
End Date:September 20, 2019
Contact:Nicoleta Stoicea, MD, PhD
Email:nicoleta.stoicea@osumc.edu
Phone:614-293-0775

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The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery

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.

The rates of PONV will be evaluated over the first 24 hours after surgery, opioid consumption
in units of morphine equivalence, and any adverse side effects will be recorded. Subjects who
are included in the research will be randomly assigned to one of two groups - one group is
the control group, receiving no TEAS, and the other group receiving TEAS. An anesthesiologist
trained in acupuncture will utilize the Excel Pointer to locate the specific acupoints
previously identified as associated with prevention PONV. Anesthesiologist will place
electrocardiogram (ECG) pads at the identified acupoints prior to surgery. Subjects will be
connected to the ES-130 (electro-therapy) device upon entering the operating room. Prior to
the surgical closure, the unblinded researcher will initiate delivery of TEAS, or not,
according to study protocol based on the randomization group of the participant. The
anesthesiologist will not know the group assignment. At the end of surgery, the subject will
be disconnected from the ES-130 and the ECG pads will be carefully removed. Researchers will
follow up with the subject in recovery regarding any occurrence and severity of PONV, adverse
events, and verbal pain scores, until 24 hours after end of surgery.

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)
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-3559
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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from
Columbus, OH
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