Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT ID: NCT07190495

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ginger group

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

Group Type ACTIVE_COMPARATOR

Ginger

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ginger

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Ben Taleb Ibtissem

Assistant Professor in Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Ibtissem BEN TALEB, M.D.

Role: CONTACT

+216 23 133 748

Facility Contacts

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Ibtissem BEN TALEB, M.D.

Role: primary

+216 23 133 748

Mechaal BEN ALI, M.D.

Role: backup

+216 98 657 034

Other Identifiers

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GINGER PONV

Identifier Type: -

Identifier Source: org_study_id

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