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

Study Overview
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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.

Official Title
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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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Dietary Supplement: Ginger
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quadruple, blind randomized, controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.<br>|
| Experimental: Ginger<br>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<br>* Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger<br>Dietary Supplement: Placebo<br>* Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of post operative Nausea and vomiting | Measured using the Rhodes index | 12 hours after surgery | 
| Severity of post operative Nausea and vomiting | Measured using the Rhodes index | 24 hours after surgery | 
| Severity of post operative Nausea and vomiting | Measured using the Rhodes index | 48 hours after surgery | 
| Severity of post operative Nausea and vomiting | Measured using the BARF scale | 12 hours after surgery | 
| Severity of post operative Nausea and vomiting | Measured using the BARF scale | 24 hours after surgery | 
| Severity of post operative Nausea and vomiting | Measured using the BARF scale | 48 hours after surgery | 
| Patient satisfaction | Measured using a questionnaire administered to patient by investigators | 48 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Nausea and Vomiting, Ginger