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

NCT03626441 | Completed Phase 2 DMC

• 1 other identifier: Anaesthesia20182
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; Ginger

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Severity of post operative Nausea and vomiting

  12 hours after surgery

• Severity of post operative Nausea and vomiting

  24 hours after surgery

• Severity of post operative Nausea and vomiting

  48 hours after surgery

• Severity of post operative Nausea and vomiting

  12 hours after surgery

• Severity of post operative Nausea and vomiting

  24 hours after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Ginger

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

Ginger DIETARY_SUPPLEMENT

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

Ginger

Placebo DIETARY_SUPPLEMENT

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

Ginger; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• Undergoing elective intra-abdominal, gynaecological surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University of the West Indies

Kingston, Kng 7, 00000, Jamaica

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyacinth Harding, DM

  UWI, Faculty of medical sciencces

  PRINCIPAL INVESTIGATOR

• Andrea Myers, MD

  UWI, Faculty of medical sciencces

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate lecturer

Model Details: Quadruple, blind randomized, controlled trial

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 13, 2018
• Study Start: December 2, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 14, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)