Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

Phase 4RecruitingNCT07190495

University Tunis El Manar102 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

102

Conditions

Postoperative Nausea and Vomiting Laparoscopic Cholecystectomy

Interventions

GingerDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, Tunisia

RECRUITING

Outcomes

Primary Outcomes

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

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.

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.

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.

Use of rescue antiemetics

The need for rescue antiemetics within 24 hours postoperatively.

Time frame: 24 hours postoperatively

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

Central Contacts

Ibtissem BEN TALEB, M.D.

CONTACT

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

Data from ClinicalTrials.gov

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