Phase 3
N=239
Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients
Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01733212 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Occurrence of Intra-operative and Post-operative Vomiting — 30; 45 Participants — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ginger (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Joel Yarmush
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Intra-operative and Post-operative Vomiting |
30; 45 | 0.07 |
Summary
SPECIFIC AIMS
* Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia
* Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups.
* Quantify post-operative analgesia and pruritus in the ginger and placebo groups
* Quantify patient satisfaction of the ginger and placebo groups
* Assess patient expectation of ginger on post-op day three
Eligibility Criteria
Inclusion Criteria
- Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital
- Signed informed consent
Exclusion Criteria
- They are unable or unwilling to take part in the study
- They have a history of an allergy to any medications used including ginger
- They have had any gastrointestinal surgery on the stomach, small intestine, or gall bladder.
- They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)
- They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold- Chiari malformation, etc.)
- They are unable to understand instructions or questions related to study
- ASA III or IV patients
Data sourced from ClinicalTrials.gov (NCT01733212). 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.