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

NCT ID: NCT01733212

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ginger

2 gm powder of ginger filled in a capsule

Group Type: EXPERIMENTAL

Ginger

Intervention Type: 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.

Placebo

2 gm of placebo pill (A capsule)

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zingiber Officinale

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Joel Yarmush

OTHER

Sponsor Role: lead

Responsible Party

Joel Yarmush

Attending Physician, Program Director (Anesthesiology)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jonathan Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Brooklyn Methodist Hospital

Locations

New York Methodist Hospital

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34002866 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23510951 (View on PubMed)

Other Identifiers

IRB:147810

Identifier Type: -

Identifier Source: org_study_id