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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Yarmush, New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT01733212
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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

Condition Intervention
Nausea
Vomiting
Drug: Ginger

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by New York Methodist Hospital:

Primary Outcome Measures:
  • effect of ginger on Intra operative and Post Operative Nausea and Vomiting [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect of ginger on pruritus and pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ginger
2 gm powder of ginger filled in a capsule
Drug: Ginger
N/A
Other Name: Zingiber Officinale
Placebo Comparator: Placebo
2 gm of placebo pill (A capsule)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733212

Locations
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
Joel Yarmush
Investigators
Principal Investigator: Jonathan Weinberg, MD New York Methodist Hospital
  More Information

No publications provided by New York Methodist Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joel Yarmush, Attending Physician, Program Director (Anesthesiology), New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT01733212     History of Changes
Other Study ID Numbers: IRB:147810, IND 110515
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York Methodist Hospital:
Nausea
Vomiting
Cesaraen
Ginger
cesarean section

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 20, 2014