NCT02473042

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

Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.

Detailed description

Study Groups: If you are eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. If you are in Group 1, you will receive light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks. If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. Electrical Stimulation: The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery. The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in. Study Procedures: Both Groups: * You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting. * You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time. Length of Study: Your participation in this study will be over once you leave the clinic after surgery. This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational. Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Conditions

• Post-Operative Nausea and Vomiting
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Electrical Stimulation	Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
DRUG	Zofran	4 mg by vein for 1 dose.
DRUG	Dexamethasone	10 mg by vein for 1 dose.
DRUG	Phenergan	6.25 mg by vein for 1 dose.
DRUG	Pepcid	10 mg by vein for 1 dose.
BEHAVIORAL	Questionnaire	Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.

Timeline

• Start date: 2016-03-01
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2015-06-16
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study