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

NCT ID: NCT03626441

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-02

Study Completion Date

2018-06-14

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Quadruple, blind randomized, controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sequentially numbered, sealed, opaque envelopes prepared and opened the evening before the surgery. Tablets containing either placebo or ginger allocated by a person not involved in any other aspect of the study and administered on the morning of surgery.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of 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.

Group Type EXPERIMENTAL

Ginger

Intervention Type DIETARY_SUPPLEMENT

Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger

Placebo

Intervention Type DIETARY_SUPPLEMENT

Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.

Interventions

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Ginger

Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger

Intervention Type DIETARY_SUPPLEMENT

Placebo

Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Patrick J Toppin

Associate lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyacinth Harding, DM

Role: PRINCIPAL_INVESTIGATOR

UWI, Faculty of medical sciencces

Andrea Myers, MD

Role: STUDY_DIRECTOR

UWI, Faculty of medical sciencces

Locations

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University of the West Indies

Kingston, Kng 7, Jamaica

Site Status

Countries

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Jamaica

Other Identifiers

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Anaesthesia20182

Identifier Type: -

Identifier Source: org_study_id

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