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Effect of TEAS on PONV After Spinal Surgery

ConditionPONV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJyoti Pandya

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • TEAS via ES-130

    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

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Transcutaneous Electrical Acupoint StimulationExperimental treatment 1 intervention
Group B: No Transcutaneous Electrical Acupoint StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

incidence of PONV

measure the incidence of PONV in spinal surgery

Time frame
up to 24 hours after surgery
2

severity of PONV

use Verbal Rating Scale (VRS) score (0-10) to rate nausea

Time frame
up to 24 hours after surgery

Secondary outcomes

1

Time to first nausea/vomiting rescue medication

Time until subject requests rescue anti-emetic therapy

Time frame
within 2 and 24 hours after surgery
2

opioid consumption (units of morphine equivalence)

compare the opioid consumption after surgery in units of morphine

Time frame
2 and 24 hours after surgery
3

incidence of adverse events

compare incidence of adverse events between groups

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jyoti Pandya

Lead sponsor

Ohio State University

Sponsor institution

Source ClinicalTrials.gov
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