Phase 4 N=180 Randomized Prevention

Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean

Nausea · Vomiting · Satisfaction

Bottom Line

View on ClinicalTrials.gov: NCT02959840 ↗

Enrolled (actual)

180

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Nausea — 44; 14; 22 Participants — p=< 0.00001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Acupressure Point P6 stimulator (Device); Metoclopramide (Drug); Ondansetron (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Rutgers, The State University of New Jersey
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Nausea	44; 14; 22	< 0.00001 sig
PRIMARY Vomiting	27; 10; 8	0.001 sig
SECONDARY Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)	33; 7; 14	0.00004 sig
SECONDARY Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)	12; 6; 5	0.1
SECONDARY Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)	16; 8; 14	0.7
SECONDARY Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)	3; 4; 0	1
SECONDARY Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)	20; 5; 4	0.001 sig
SECONDARY Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)	10; 1; 3	0.008 sig
SECONDARY Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)	9; 4; 6	0.2
SECONDARY Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)	0; 2; 0	0.5
SECONDARY Satisfaction of Anti-emetic Treatment	49; 58; 55	0.02 sig
SECONDARY Overall Anesthetic Care Satisfaction	53; 58; 56	0.2

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.

Eligibility Criteria

Inclusion Criteria

Female subjects ages 18 to 45
Subjects with American Society of Anesthesiologists (ASA) Class I or II
Subjects with elective primary or repeat cesarean delivery
Subjects who receive combined spinal epidural anesthesia
English and non-English speaking subjects will be included in the study

Exclusion Criteria

Female subjects <18 years of age
Subjects requiring emergent cesarean delivery
History of placenta accrete
Multiple gestation pregnancy
ASA status III or higher
Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
History of any chronic medication use (other than prenatal vitamins), including inhaler medications
Current urinary tract infection, pneumonia, or otitis media

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Data sourced from ClinicalTrials.gov (NCT02959840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.