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New treatment option for PONV
Official title Effect of TEAS on PONV After Spinal Surgery
ClinicalTrials.gov ID: NCT03187535
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.