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NCT Number: NCT03626441

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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of the West Indies

Kingston, Kng 7, 00000, Jamaica

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ginger

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Incidence of post operative nausea or vomiting

    Time frame: 12 hours after surgery

    The proportion of patient who have any episodes of nausea or vomiting following surgery

Secondary outcomes

  1. Severity of post operative Nausea and vomiting

    Time frame: 12 hours after surgery

    Measured using the Rhodes index

  2. Severity of post operative Nausea and vomiting

    Time frame: 24 hours after surgery

    Measured using the Rhodes index

  3. Severity of post operative Nausea and vomiting

    Time frame: 48 hours after surgery

    Measured using the Rhodes index

  4. Severity of post operative Nausea and vomiting

    Time frame: 12 hours after surgery

    Measured using the BARF scale

  5. Severity of post operative Nausea and vomiting

    Time frame: 24 hours after surgery

    Measured using the BARF scale

  6. Severity of post operative Nausea and vomiting

    Time frame: 48 hours after surgery

    Measured using the BARF scale

  7. Patient satisfaction

    Time frame: 48 hours post surgery

    Measured using a questionnaire administered to patient by investigators

Sponsors and collaborators

Lead sponsor

The University of The West Indies

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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