Ginger to prevent nausea and vomiting after laparoscopic gallbladder removal
Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial
This test will see if taking 800 mg of ginger two hours before laparoscopic gallbladder removal reduces nausea and vomiting in the first 24 hours after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Tunis El Manar Academic / other |
| Locations | 1 site (Nabeul, Nabeul Governorate) |
| Trial ID | NCT07190495 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective laparoscopic cholecystectomy will receive a single oral dose of 800 mg ginger two hours before anesthesia or a matching placebo, and postoperative nausea and vomiting will be tracked for 24 hours. The trial enrolls patients aged 18 and older with ASA physical status I–III who can provide informed consent, while excluding those with ginger allergy, bleeding disorders, severe prior PONV, recent antiemetic or corticosteroid use, pregnancy or breastfeeding, or active gastrointestinal or liver disease. Primary outcomes include the incidence and severity of PONV and the need for rescue antiemetic medications in the first postoperative day. The randomized placebo-controlled design tests a simple, low-cost preoperative intervention that could be added to standard care if effective.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) scheduled for elective laparoscopic cholecystectomy with ASA I–III who are able to give informed consent and are not pregnant or breastfeeding and have no ginger allergy or bleeding disorder.
Not a fit: Patients with a history of severe PONV (Apfel score of 4), active gastrointestinal or liver disease, current anticoagulant therapy, recent preoperative antiemetic or corticosteroid use, pregnancy, or breastfeeding are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a single preoperative dose of ginger could reduce early postoperative nausea and vomiting, decrease use of rescue antiemetics, and improve patient comfort after gallbladder surgery.
How similar studies have performed: Previous randomized trials and meta-analyses of preoperative ginger for PONV have reported modest reductions in nausea and vomiting, but results have been inconsistent across studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Scheduled for elective laparoscopic cholecystectomy under general anesthesia. * American Society of Anesthesiologists (ASA) physical status I-III. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Known allergy or hypersensitivity to ginger * Documented history of bleeding disorders or current treatment with anticoagulant agents * History of severe postoperative nausea and vomiting or an Apfel score of 4 * Administration of antiemetic drugs or corticosteroids during the preoperative period * Pregnancy or breastfeeding * Active gastrointestinal or liver disease
Where this trial is running
Nabeul, Nabeul Governorate
- Mohamed Taher Maamouri University Hospital — Nabeul, Nabeul Governorate, Tunisia (Recruiting)
Study contacts
- Study coordinator: Ibtissem BEN TALEB, M.D.
- Email: ibtissem.bentaleb@fmt.utm.tn
- Phone: +216 23 133 748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.