Clinical trial NCT01733212: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Cesaraen
Ginger
cesarean section
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 239
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Occurrence of Intra-operative and Post-operative Vomiting
timeFrame: During surgery (1 hour) and thru 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Jonathan Weinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.