Clinical trial NCT01733212
Conditions: Nausea Vomiting
Keywords: Nausea Vomiting Cesaraen Ginger cesarean section
Sponsor: Joel Yarmush
Start date: 2010-06-01; Completion date: 2011-07-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 2 gm powder of ginger filled in a capsule arm 2: 2 gm of placebo pill (A capsule)
Interventions: intervention 1: Ginger intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: 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. intervention 2: Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.

Protocol documents: