Nausea, Vomiting
Conditions
Keywords
Nausea, Vomiting, Cesaraen, Ginger, cesarean section
Brief 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
Detailed description
Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and antacid regimen will be continued for both groups. Initial blood pressure, pulse and hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the patient into the operating room. A baseline questionnaire will be given to the patients to assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o PONV, medical problems, any medication used within past 24 hrs, education and occupation. Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual manner. All standard monitoring will be applied and vital signs recorded for the entirety of the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting episodes will be noted. In addition the following will be recorded: if uterus was exteriorized, any medications used by the anesthesiologist (other than ephedrine and phenylephrine), and estimated blood loss. Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1) or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU). Thirty minutes after the medication is given, patients will be asked to rate their nausea, level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded. Medications given for nausea will be continued in the post-operative period for both groups. The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess platelet function.
Interventions
DRUGGinger
Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
DRUGPlacebo Oral Tablet
Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
Sponsors
Joel Yarmush
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Intra-operative and Post-operative Vomiting | During surgery (1 hour) and thru 72 hours after surgery | Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups. |
Countries
United States
Participant flow
Recruitment details
Enrollment period: June 03, 2010 to April 12, 2011 Location: New York Methodist Hospital, Department of Obstetrics and Gynecology
Participants by arm
| Arm | Count |
|---|---|
| Ginger 2 gm powder of ginger filled in a capsule | 116 |
| Placebo 2 gm of placebo pill (A capsule) | 123 |
| Total | 239 |
Baseline characteristics
| Characteristic | Placebo | Ginger | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 123 Participants | 116 Participants | 239 Participants |
| Age, Continuous | 33.0 years STANDARD_DEVIATION 4.8 | 32.8 years STANDARD_DEVIATION 5.3 | 32.9 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 123 participants | 116 participants | 239 participants |
| Sex: Female, Male Female | 123 Participants | 116 Participants | 239 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 123 |
| other Total, other adverse events | 0 / 116 | 0 / 123 |
| serious Total, serious adverse events | 0 / 116 | 0 / 123 |
Outcome results
Primary
Occurrence of Intra-operative and Post-operative Vomiting
Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
Time frame: During surgery (1 hour) and thru 72 hours after surgery
Population: Number of participants who had vomiting in each group is compared to the other group using Chi square test
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ginger | Occurrence of Intra-operative and Post-operative Vomiting | 30 Participants |
| Placebo | Occurrence of Intra-operative and Post-operative Vomiting | 45 Participants |
Comparison: Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.p-value: 0.07Chi-squared