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Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy

Not Applicable
Recruiting
Conditions
Postoperative Nausea and Vomiting
Laparoscopic Cholecystectomy
Interventions
Drug: Placebo
Registration Number
NCT07190495
Lead Sponsor
University Tunis El Manar
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
102
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ginger groupGingerPatients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy
Placebo groupPlaceboPatients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy
Primary Outcome Measures
NameTimeMethod
Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery2 hours after surgery.

Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.

Secondary Outcome Measures
NameTimeMethod
Recurrence of PONV beyond 2 hours postoperativelyFrom 2 hours to 24 hours after surgery.

Proportion of participants who experienced at least one additional episode of nausea or vomiting occurring after the 2-hour postoperative time point.

Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery24 hours after surgery.

Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.

Total number of vomiting episodesWithin 24 hours post-surgery.

Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery.

Use of rescue antiemetics24 hours postoperatively

The need for rescue antiemetics within 24 hours postoperatively.

Incidence of ginger-related adverse eventsWithin 24 hours after surgery

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.

Trial Locations

Locations (1)

Mohamed Taher Maamouri University Hospital

🇹🇳

Nabeul, Nabeul Governorate, Tunisia

Mohamed Taher Maamouri University Hospital
🇹🇳Nabeul, Nabeul Governorate, Tunisia
Ibtissem BEN TALEB, M.D.
Contact
+216 23 133 748
ibtissem.bentaleb@fmt.utm.tn
Mechaal BEN ALI, M.D.
Contact
+216 98 657 034
mechaal_benali@yahoo.fr

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