Postoperative Nausea and VomitingPhase 4GINGER-PONVNCT07190495
Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy
A Phase 4 study testing Ginger in people with Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTunisia
- Study dates
- 5 Jul 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Mohamed Taher Maamouri University Hospital
Nabeul, Nabeul Governorate, 8000
Ibtissem BEN TALEB, M.D., +216 23 133 748, ibtissem.bentaleb@fmt.utm.tn
Mechaal BEN ALI, M.D., +216 98 657 034, mechaal_benali@yahoo.fr
About this study
Official title: Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial
This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy.
- Being tested
- Ginger, Placebo
- Keywords
- Ginger, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy
PlaceboDrug
Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Ginger group | Active comparator | Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy Receives: Drug: Ginger |
| Placebo group | Placebo comparator | Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery
Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.
Measured: 2 hours after surgery.
Secondary outcomes (5)
Recurrence of PONV beyond 2 hours postoperatively
Proportion of participants who experienced at least one additional episode of nausea or vomiting occurring after the 2-hour postoperative time point.
Measured: From 2 hours to 24 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery
Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.
Measured: 24 hours after surgery.
Total number of vomiting episodes
Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery.
Measured: Within 24 hours post-surgery.
Use of rescue antiemetics
The need for rescue antiemetics within 24 hours postoperatively.
Measured: 24 hours postoperatively
Incidence of ginger-related adverse events
Number of participants experiencing adverse events known to be associated with ginger, including gastrointestinal discomfort (heartburn, abdominal pain, bloating, diarrhea), bleeding, or allergic reactions in the 24 hours after surgery.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start5 Jul 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Taleb Ibtissem, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190495
- Sponsor's protocol ID
- GINGER PONV
- Acronym
- GINGER-PONV
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07190495
- Acronym / sponsor ID
- GINGER-PONV / GINGER PONV
- Keywords
- Ginger, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger group | Active comparator | Drug: GingerPatients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy |
| Placebo group | Placebo comparator | Drug: PlaceboPatients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerPatients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy | Drug | Ginger group |
| PlaceboPatients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy | Drug | Placebo group |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery
Time frame: 2 hours after surgery.
Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.
5 secondary outcomes
Recurrence of PONV beyond 2 hours postoperatively
Time frame: From 2 hours to 24 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery
Time frame: 24 hours after surgery.
Total number of vomiting episodes
Time frame: Within 24 hours post-surgery.
Use of rescue antiemetics
Time frame: 24 hours postoperatively
Incidence of ginger-related adverse events
Time frame: Within 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Nausea and Vomiting
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ginger in people with Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibtissem BEN TALEB, M.D. (+216 23 133 748, ibtissem.bentaleb@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery (time frame: 2 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.