Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients

Joel Yarmush

Status and phase

Completed

Phase 3

Phase 2

Conditions

Vomiting

Nausea

Treatments

Drug: Placebo Oral Tablet

Drug: Ginger

Study type

Interventional

Funder types

Other

Identifiers

NCT01733212

IRB:147810

Details and patient eligibility

About

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

Full 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.

Enrollment

239 patients

Sex

Female

Ages

20 to 49 years old

Volunteers

Accepts Healthy Volunteers

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