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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733212
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : May 11, 2018
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Joel Yarmush, New York Presbyterian Brooklyn Methodist Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Ginger Drug: Placebo Oral Tablet Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
Study Start Date : June 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ginger
2 gm powder of ginger filled in a capsule
 Drug: Ginger
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 Name: Zingiber Officinale
Placebo Comparator: Placebo
2 gm of placebo pill (A capsule)
 Drug: Placebo Oral Tablet
Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733212


Locations
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United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
Joel Yarmush
Investigators
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Principal Investigator: Jonathan Weinberg, MD New York Presbyterian Brooklyn Methodist Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joel Yarmush, Attending Physician, Program Director (Anesthesiology), New York Presbyterian Brooklyn Methodist Hospital
ClinicalTrials.gov Identifier: NCT01733212    
Other Study ID Numbers: IRB:147810
First Posted: November 26, 2012    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: September 10, 2021
Last Verified: August 2018
Keywords provided by Joel Yarmush, New York Presbyterian Brooklyn Methodist Hospital:
Nausea
Vomiting
Cesaraen
Ginger
cesarean section
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes