Your session is about to expire
← Back to Search
TEAS for Postoperative Nausea and Vomiting
N/A
Recruiting
Led By Sergio Bergese, MD
Research Sponsored by Jyoti Pandya
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 and 24 hours after surgery
Awards & highlights
Study Summary
This trial will use a needle-free form of acupuncture that sends electrical stimulations to pressure points on the body. They will compare the levels of post-operative nausea and vomiting in those who receive this treatment to those who do not.
Who is the study for?
This trial is for men and women over 18, with an ASA classification I-III, undergoing elective spinal surgery lasting no more than four hours. Participants must be able to consent. Excluded are those with certain medical conditions like vestibular disease, recent nausea or drug use, poorly controlled diabetes, metal/electrical implants, skin issues at the stimulation site, major psychiatric conditions, recent chemo/radiation therapy or investigational product use.Check my eligibility
What is being tested?
The study tests if TEAS (a needleless acupuncture using electrostimulation) can reduce post-operative nausea and vomiting in patients after spinal surgery compared to a group without TEAS. It's a randomized double-blind trial meaning participants are randomly assigned to groups and neither they nor the researchers know who receives which treatment until after the results are collected.See study design
What are the potential side effects?
While specific side effects of TEAS aren't detailed here, similar treatments may cause mild skin irritation at the stimulation site or discomfort during treatment. The risk of serious side effects is generally considered low.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderate, with or without severe systemic disease.
Select...
I am scheduled for a spinal surgery that will last less than 4 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 and 24 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 and 24 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
incidence of PONV
severity of PONV
Secondary outcome measures
Time to first nausea/vomiting rescue medication
incidence of adverse events
opioid consumption (units of morphine equivalence)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcutaneous Electrical Acupoint StimulationExperimental Treatment1 Intervention
Subjects in the "Transcutaneous Electrical Acupoint Stimulation" (TEAS) group will receive 20 minutes of TEAS via ES-130 beginning at the time ondansetron is administered (usually given 30 minutes before the end of surgery), for prevention of PONV.
Group II: No Transcutaneous Electrical Acupoint StimulationPlacebo Group1 Intervention
Subjects in the "No Transcutaneous Electrical Acupoint Stimulation" group will not receive any TEAS, although they will have the acupoints identified and ECG patches placed. The device will not be connected to the electrodes of the ES-130 device at the end of surgery, and no TEAS will be delivered.
Find a Location
Who is running the clinical trial?
Jyoti PandyaLead Sponsor
Sergio Bergese, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
5 Previous Clinical Trials
306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood sugar levels are not well-controlled.My health is good to moderate, with or without severe systemic disease.I have had a spinal block procedure.I have a long-term issue with dizziness or balance.I haven't had nausea or used specific nausea medications in the last 3 days.I haven't had chemotherapy or radiation within a week before surgery.I haven't used any experimental drugs within 3 months before surgery.I have had a limb amputated or severely burned.I don't have skin conditions that could affect acupuncture areas.I am able and willing to agree to participate.I am scheduled for a spinal surgery that will last less than 4 hours.I am 18 years old or older.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are currently engaging in the research?
"Affirmative. According to data available on clinicaltrials.gov, this trial is currently enrolling participants; its initial listing was published on August 1st 2018 and the most recent update occurred January 4th 2022. 72 patients must be recruited from a single medical centre in order for the study to complete successfully."
Answered by AI
Are there still opportunities for people to enrol in this trial?
"That is correct. Per the information on clinicaltrials.gov, this research project commenced recruiting participants in August 2018 and has been actively seeking candidates since then; they are targeting 72 patients at 1 location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger