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Procedure

Electrical Stimulation for Post-Operative Nausea and Vomiting

N/A

Waitlist Available

Led By Alicia M. Kowalski, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of patient reported PONV, CINV or motion sickness

Female gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial is testing whether electrical stimulation during surgery is a feasible way to reduce pain for women having breast surgery.

Who is the study for?

This trial is for adult women who have experienced nausea or vomiting after surgery, chemotherapy, or due to motion sickness. They must be scheduled for breast surgery and able to give informed consent. It's not suitable for those with certain medical conditions like severe upper limb deformities, bowel obstruction, pacemakers, pre-existing nausea/vomiting, CNS disorders causing weakness/paresis in limbs, metal implants in the treatment area, pregnancy, skin infections near the stimulation site or substance abuse.Check my eligibility

What is being tested?

The study tests if light electrical stimulation at a wrist point during breast surgery can prevent post-operative nausea and vomiting (PONV). Participants will also receive standard anti-nausea medications such as Phenergan (promethazine), Zofran (ondansetron), Dexamethasone and Pepcid (famotidine) alongside completing questionnaires about their symptoms.See study design

What are the potential side effects?

Possible side effects from the electrical stimulation may include discomfort at the wrist site. Standard medications used like Phenergan can cause drowsiness; Zofran might lead to headaches; Dexamethasone could result in increased appetite; Pepcid generally has fewer side effects but may sometimes cause fatigue or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced nausea or vomiting from motion, chemotherapy, or anesthesia.

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I am female.

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I am scheduled for breast surgery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of Electrical Stimulation of P6 Combined with Prophylactic Anti-Emetics Versus Pharmacological Prophylaxis Alone in Preventing the Incidence of Post-Operative Nausea and Vomiting (PONV)

Secondary outcome measures

Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Electrical Stimulation + Standard of Care AntiemeticsExperimental Treatment6 Interventions

Participants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Group II: Standard of Care AntiemeticsActive Control5 Interventions

Participants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaire

2014

Completed Phase 2

~20090

Dexamethasone

2007

Completed Phase 4

~2590

Electrical Stimulation

2013

Completed Phase 2

~410

Phenergan

2014

Completed Phase 1

~20

Zofran

2019

Completed Phase 4

~680

Pepcid

1998

Completed Phase 1

~30

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,593 Total Patients Enrolled

Alicia M. Kowalski, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Electrical Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02473042 — N/A

Postoperative Nausea and Vomiting Research Study Groups: Standard of Care Antiemetics, Electrical Stimulation + Standard of Care Antiemetics

Postoperative Nausea and Vomiting Clinical Trial 2023: Electrical Stimulation Highlights & Side Effects. Trial Name: NCT02473042 — N/A

Electrical Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02473042 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical ailments does Phenergan typically provide relief for?

"Phenergan is a common pharmaceutical used to eradicate helicobacter pylori, as well as treating the symptoms of synovitis, ophthalmia, sympathetic disorders, and branch retinal vein occlusion."

Answered by AI

What is the magnitude of participants for this experiment?

"This research program is not accepting patients at the moment. Initially posted on February 1st 2016, with a last edit occurring on June 29th 2022, there are presently 2712 trials for individuals with breast cancer and 576 studies involving Phenergan actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

2016. "Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02473042.