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RecruitingNCT07190495GINGER-PONVUpdated Apr 28, 2026

Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

A Phase 4 interventional study of Ginger and Placebo in Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, sponsored by University Tunis El Manar. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by University Tunis El Manar · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
  • Laparoscopic Cholecystectomy

Keywords

  • Ginger
  • Postoperative Nausea and Vomiting
  • Laparoscopic Cholecystectomy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    Ginger group

    Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy

    Drug: Ginger

  • Placebo comparator
    Placebo group

    Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy

    Drug: Placebo

Interventions

  • DrugGinger

    Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy

  • DrugPlacebo

    Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 hours after surgery.

Secondary outcomes

  1. 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.

    Time frame: From 2 hours to 24 hours after surgery.

  2. 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.

    Time frame: 24 hours after surgery.

  3. Total number of vomiting episodes

    Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery.

    Time frame: Within 24 hours post-surgery.

  4. Use of rescue antiemetics

    The need for rescue antiemetics within 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  5. 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.

    Time frame: Within 24 hours after surgery

06

Study locations

1 of 1 sites recruiting
  • Mohamed Taher Maamouri University Hospital
    Nabeul, Nabeul Governorate 8000, Tunisia
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07190495
Lead sponsor
University Tunis El Manar
Responsible party
Ben Taleb Ibtissem (Assistant Professor in Anesthesiology and Intensive Care, University Tunis El Manar) — Principal investigator
First posted
Sep 24, 2025
Start date
Jul 5, 2025
Primary completion
Aug 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 28, 2026

Study contacts

Ibtissem BEN TALEB, M.D.
Contact
ibtissem.bentaleb@fmt.utm.tn
+216 23 133 748

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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