Back to resultsThe Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 2
Locations
Jamaica
Study Type
Interventional
Intervention
Ginger
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Ginger
Eligibility 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.
Sites / Locations
- University of the West Indies
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Ginger
Arm Description
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.
Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
Outcomes
Primary Outcome Measures
Incidence of post operative nausea or vomiting
The proportion of patient who have any episodes of nausea or vomiting following surgery
Secondary Outcome Measures
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Patient satisfaction
Measured using a questionnaire administered to patient by investigators
Full Information
NCT ID
NCT03626441
First Posted
July 14, 2018
Last Updated
August 7, 2018
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT03626441
Brief Title
The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2, 2017 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting, Ginger
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Quadruple, blind randomized, controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ginger
Arm Type
Experimental
Arm Description
Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger
Intervention Description
Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.
Primary Outcome Measure Information:
Title
Incidence of post operative nausea or vomiting
Description
The proportion of patient who have any episodes of nausea or vomiting following surgery
Time Frame
12 hours after surgery
Secondary Outcome Measure Information:
Title
Severity of post operative Nausea and vomiting
Description
Measured using the Rhodes index
Time Frame
12 hours after surgery
Title
Severity of post operative Nausea and vomiting
Description
Measured using the Rhodes index
Time Frame
24 hours after surgery
Title
Severity of post operative Nausea and vomiting
Description
Measured using the Rhodes index
Time Frame
48 hours after surgery
Title
Severity of post operative Nausea and vomiting
Description
Measured using the BARF scale
Time Frame
12 hours after surgery
Title
Severity of post operative Nausea and vomiting
Description
Measured using the BARF scale
Time Frame
24 hours after surgery
Title
Severity of post operative Nausea and vomiting
Description
Measured using the BARF scale
Time Frame
48 hours after surgery
Title
Patient satisfaction
Description
Measured using a questionnaire administered to patient by investigators
Time Frame
48 hours post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyacinth Harding, DM
Organizational Affiliation
UWI, Faculty of medical sciencces
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Myers, MD
Organizational Affiliation
UWI, Faculty of medical sciencces
Official's Role
Study Director
Facility Information:
Facility Name
University of the West Indies
City
Kingston
State/Province
Kng 7
ZIP/Postal Code
00000
Country
Jamaica
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make patient data available to other researchers
Learn more about this trial
The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting
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