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Completed

NCT Number: NCT01733212

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

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

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Key information

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger

Drug

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.

Other names: Zingiber Officinale

Placebo oral tablet

Drug

Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.

Primary outcomes

  1. Occurrence of Intra-operative and Post-operative Vomiting

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Joel Yarmush

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2012
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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