The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting

An Evaluation of the Effectiveness of a Single Dose of Preoperative Ginger on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Elective Gynaecological Surgery

This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ginger

Detailed Description

Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.

Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Jamaica
  • Kng 7
    • Kingston, Kng 7, Jamaica, 00000
      • University of the West Indies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18 or above
• Undergoing elective intra-abdominal, gynaecological surgery

Exclusion Criteria:

• Allergy to ginger, ginger by-products or cornstarch
• Gastroesophageal reflux disease (GERD)
• Allergy to any of the Anaesthesia Agents
• Inability to swallow capsules.
• psychiatric illness which prevents patients giving informed consent.
• Psychological which prevents patients giving informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.	Dietary supplement: Placebo; Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.
Experimental: Ginger; Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.	Dietary supplement: Placebo; Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.; Dietary supplement: Ginger; Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post operative nausea or vomiting	The proportion of patient who have any episodes of nausea or vomiting following surgery	12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of post operative Nausea and vomiting	Measured using the Rhodes index	12 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the Rhodes index	24 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the Rhodes index	48 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the BARF scale	12 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the BARF scale	24 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the BARF scale	48 hours after surgery
Patient satisfaction	Measured using a questionnaire administered to patient by investigators	48 hours post surgery

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Hyacinth Harding, DM, UWI, Faculty of medical sciencces; Study Director: Andrea Myers, MD, UWI, Faculty of medical sciencces

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Ginger
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: Anaesthesia20182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make patient data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No