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

Phase 2

Completed

• Conditions: Vomiting; Nausea
• Interventions: Drug: Placebo Oral Tablet; Drug: Ginger

• Registration Number: NCT01733212
• Lead Sponsor: Joel Yarmush

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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-24
• Study First Posted: 2012-11-26
• Results First Submitted: 2013-04-30
• Results First Submitted QC: 2018-04-10
• Results First Posted: 2018-05-11
• Status Verified: 2018-08
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	2 gm of placebo pill (A capsule)
Ginger	Ginger	2 gm powder of ginger filled in a capsule

Primary Outcome Measures

Name	Time	Method
Occurrence of Intra-operative and Post-operative Vomiting	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.

Trial Locations

Locations (1)

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States