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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger group | Active Comparator | Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy |
|
| Placebo group | Placebo Comparator | Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger | Drug | Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 2 hours to 24 hours after surgery. |
| Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibtissem BEN TALEB, M.D. | Contact | +216 23 133 748 | ibtissem.bentaleb@fmt.utm.tn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Taher Maamouri University Hospital | Recruiting | Nabeul | Nabeul Governorate | 8000 | Tunisia |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Placebo | Drug | Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy |
|
Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery. |
| 24 hours after surgery. |
| Total number of vomiting episodes | Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery. | Within 24 hours post-surgery. |
| Use of rescue antiemetics | The need for rescue antiemetics within 24 hours postoperatively. | 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. | Within 24 hours after surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |