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Recruiting NCT07190495

Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

Phase IV Interventional Postoperative Nausea and Vomiting Laparoscopic Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ginger, Placebo.
Who it may be relevant to
Registry conditions: Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tunisia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Ginger
    Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy
  • Drug Placebo
    Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy

Primary outcome measures

  • Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery [Time frame: 2 hours after surgery.]
Secondary outcome measures (5)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Tunisia · 1 center
  • Mohamed Taher Maamouri University Hospital — Nabeul

Identifiers

NCT: NCT07190495 · GINGER PONV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗