Health Trials

Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

ConditionsPostoperative Nausea and VomitingLaparoscopic Cholecystectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Tunis El Manar

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ginger

    Drug

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

  • Placebo

    Drug

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

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Ginger groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Tunis El Manar

Lead sponsor

Source ClinicalTrials.gov
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