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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ginger
Placebo Oral Tablet
Sponsored by
Joel Yarmush
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Nausea, Vomiting, Cesaraen, Ginger, cesarean section

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger

Placebo

Arm Description

2 gm powder of ginger filled in a capsule

2 gm of placebo pill (A capsule)

Outcomes

Primary Outcome Measures

Occurrence of Intra-operative and Post-operative Vomiting
Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2012
Last Updated
September 8, 2021
Sponsor
Joel Yarmush
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1. Study Identification

Unique Protocol Identification Number
NCT01733212
Brief Title
Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients
Official Title
Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joel Yarmush

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Nausea, Vomiting, Cesaraen, Ginger, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger
Arm Type
Experimental
Arm Description
2 gm powder of ginger filled in a capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 gm of placebo pill (A capsule)
Intervention Type
Drug
Intervention Name(s)
Ginger
Other Intervention Name(s)
Zingiber Officinale
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
Primary Outcome Measure Information:
Title
Occurrence of Intra-operative and Post-operative Vomiting
Description
Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
Time Frame
During surgery (1 hour) and thru 72 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Weinberg, MD
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34002866
Citation
Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Results Reference
derived
PubMed Identifier
23510951
Citation
Kalava A, Darji SJ, Kalstein A, Yarmush JM, SchianodiCola J, Weinberg J. Efficacy of ginger on intraoperative and postoperative nausea and vomiting in elective cesarean section patients. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):184-8. doi: 10.1016/j.ejogrb.2013.02.014. Epub 2013 Mar 17.
Results Reference
derived

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

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