Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients
- 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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.|
- effect of ginger on Intra operative and Post Operative Nausea and Vomiting [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- effect of ginger on pruritus and pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Ginger
2 gm powder of ginger filled in a capsule
Other Name: Zingiber Officinale
Placebo Comparator: Placebo
2 gm of placebo pill (A capsule)
Two hundred and forty-two 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733212
|United States, New York|
|New York Methodist Hospital|
|Brooklyn, New York, United States, 11215|
|Principal Investigator:||Jonathan Weinberg, MD||New York Methodist Hospital|