Using electroacupuncture to reduce nausea after spinal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) in preventing post-operative nausea and vomiting (PONV) in patients undergoing spinal surgery. In a randomized, double-blind design, participants will be assigned to either receive TEAS or not during their surgery. The study will monitor the incidence of PONV, opioid consumption, and any adverse effects for 24 hours post-surgery. An anesthesiologist trained in acupuncture will apply the TEAS using specific acupoints identified for their potential to alleviate nausea.

Why it matters

Who can join: the full rules

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)

Where it's running

• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Sergio Bergese, MD — Ohio State University
• Study coordinator: Juan Fiorda, MD, PhD
• Email: juan.fiorda@osumc.edu
• Phone: 614-293-3559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.