Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT07190495 | Recruiting Phase 4

• 1 other identifier: GINGER PONV
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy

Keywords

Ginger; Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy

Outcome Measures

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.

  2 hours after surgery.

Secondary Outcomes (5)

• Recurrence of PONV beyond 2 hours postoperatively

  From 2 hours to 24 hours after surgery.

• Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery

  24 hours after surgery.

• Total number of vomiting episodes

  Within 24 hours post-surgery.

• Use of rescue antiemetics

  24 hours postoperatively

• Incidence of ginger-related adverse events

  Within 24 hours after surgery

Study Arms (2)

Ginger group

ACTIVE COMPARATOR

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

Drug: Ginger

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ginger DRUG

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

Ginger group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, 8000, Tunisia

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Ibtissem BEN TALEB, M.D.

CONTACT

+216 23 133 748; ibtissem.bentaleb@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 24, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

TU (1)