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

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ClinicalTrials.gov Identifier: NCT03626441
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Patrick J Toppin, 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Dietary Supplement: Ginger Dietary Supplement: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Quadruple, blind randomized, controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : December 2, 2017
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626441


Locations
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Jamaica
University of the West Indies
Kingston, Kng 7, Jamaica, 00000
Sponsors and Collaborators
The University of The West Indies
Investigators
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Principal Investigator: Hyacinth Harding, DM UWI, Faculty of medical sciencces
Study Director: Andrea Myers, MD UWI, Faculty of medical sciencces

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Responsible Party: Patrick J Toppin, Associate lecturer, The University of The West Indies
ClinicalTrials.gov Identifier: NCT03626441     History of Changes
Other Study ID Numbers: Anaesthesia20182
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make patient data available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick J Toppin, The University of The West Indies:
Postoperative Nausea and Vomiting
Ginger
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes