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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626441
• Other study ID #: Anaesthesia20182
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: August 2018
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 14, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Dietary Supplement:
• Ginger
Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger
• Placebo
Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.

Locations

Country	Name	City	State
Jamaica	University of the West Indies	Kingston	Kng 7

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

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