The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Location status: Recruiting
Location contact
Juan Fiorda, MD
CONTACT
Sergio D Bergese, MD
CONTACT
NCT Number: NCT03187535
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
Juan Fiorda, MD
CONTACT
Sergio D Bergese, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 24 hours after surgery
measure the incidence of PONV in spinal surgery
Time frame: up to 24 hours after surgery
use Verbal Rating Scale (VRS) score (0-10) to rate nausea
Time frame: within 2 and 24 hours after surgery
Time until subject requests rescue anti-emetic therapy
Time frame: 2 and 24 hours after surgery
compare the opioid consumption after surgery in units of morphine
Time frame: 24 hours after surgery
compare incidence of adverse events between groups
Contact information is provided by the study sponsor or research team.
Alberto Uribe, MD
CONTACT
Juan Fiorda, MD, PhD
CONTACT
Jyoti Pandya
Other
The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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