Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
NCT02959840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2017-09-25
Summary
The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during elective cesarean section under regional anesthesia.
Conditions
Interventions
- DEVICE
-
Acupressure Point P6 stimulator
This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.
- DRUG
-
Metoclopramide
10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
- DRUG
-
Ondansetron
8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
Sponsors & Collaborators
-
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Shaul Cohen, MD · Robert Wood Johnson University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2016-03-31
- Completion
- 2017-08-23
Countries
- United States
Study Locations
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