Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy
- Conditions
- Postoperative Nausea and VomitingLaparoscopic 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
- 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.
- 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
Group Intervention Description Ginger group Ginger Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy Placebo group Placebo Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy
- Primary Outcome Measures
Name Time Method Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery 2 hours after surgery. Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.
- Secondary Outcome Measures
Name Time Method Recurrence of PONV beyond 2 hours postoperatively From 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-surgery 24 hours after surgery. Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.
Total number of vomiting episodes Within 24 hours post-surgery. Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery.
Use of rescue antiemetics 24 hours postoperatively The need for rescue antiemetics within 24 hours postoperatively.
Incidence of ginger-related adverse events Within 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, TunisiaIbtissem BEN TALEB, M.D.Contact+216 23 133 748ibtissem.bentaleb@fmt.utm.tnMechaal BEN ALI, M.D.Contact+216 98 657 034mechaal_benali@yahoo.fr
