Trial Outcomes & Findings for Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean (NCT NCT02959840)

NCT ID: NCT02959840

Last Updated: 2017-09-25

Results Overview

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: During the surgical procedure
• Results posted on: 2017-09-25

Participant Flow

Participant milestones

Measure	Control No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Overall Study STARTED	60	60	60
Overall Study COMPLETED	60	60	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=180 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=60 Participants	60 Participants n=60 Participants	60 Participants n=60 Participants	180 Participants n=180 Participants
Age, Categorical >=65 years	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=180 Participants
Sex: Female, Male Female	60 Participants n=60 Participants	60 Participants n=60 Participants	60 Participants n=60 Participants	180 Participants n=180 Participants
Sex: Female, Male Male	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=180 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	60 participants n=60 Participants	60 participants n=60 Participants	60 participants n=60 Participants	180 participants n=180 Participants

PRIMARY outcome

Timeframe: During the surgical procedure

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Nausea	44 Participants	14 Participants	22 Participants

PRIMARY outcome

Timeframe: During the surgical procedure

The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Vomiting	27 Participants	10 Participants	8 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)	33 Participants	7 Participants	14 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)	12 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)	16 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)	3 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)	20 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)	10 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)	9 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Satisfaction of Anti-emetic Treatment	49 Participants	58 Participants	55 Participants

SECONDARY outcome

Timeframe: During the surgical procedure

Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.

Outcome measures

Measure	Control n=60 Participants No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	Metoclopramide, Ondansetron n=60 Participants 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupressure Point P6 Stimulator n=60 Participants Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Overall Anesthetic Care Satisfaction	53 Participants	58 Participants	56 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide, Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acupressure Point P6 Stimulator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shaul Cohen, M.D., Professor of Clinical Anesthesiology, Director of Obstetric Anesthesia

Rutgers-Robert Wood Johnson Medical School

Phone: 732-937-8841

Email: cohensh@rwjms.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place