Effect of TEAS on PONV After Spinal Surgery
The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
Jyoti Pandya
72 participants
Aug 1, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria14
- 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)
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Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03187535