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

Phase 2

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Dietary Supplement: Ginger; Dietary Supplement: Placebo

• Registration Number: NCT03626441
• Lead Sponsor: The University of The West Indies

Brief 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.

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 Timeline

• Study Start: 2017-12-02
• Primary Completion: 2018-06-12
• Study Completion: 2018-06-14
• Study First Submitted: 2018-07-14
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginger	Placebo	Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
Placebo	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.
Ginger	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.

Primary Outcome Measures

Name	Time	Method
Incidence of post operative nausea or vomiting	12 hours after surgery	The proportion of patient who have any episodes of nausea or vomiting following surgery

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	48 hours post surgery	Measured using a questionnaire administered to patient by investigators
Severity of post operative Nausea and vomiting	48 hours after surgery	Measured using the BARF scale

Trial Locations

Locations (1)

University of the West Indies; 🇯🇲 Kingston, Kng 7, Jamaica