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The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).
Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Active Comparator |
| |
| Chewing Gum | Experimental |
| |
| Ondansetron + Chewing Gum | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron (Zofran) | Drug | 4 mg IV push |
| |
| chewing gum |
| Measure | Description | Time Frame |
|---|---|---|
| Complete cessation of PONV with no recurrence and no rescue medication | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | post-operative period ( up to 3 hours) | |
| Quantity of rescue treatment modalities used | immediately after PONV start until complete resolution of symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2286697 | Result | Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
Peppermint sugar free chewing gum |
|
| Ondansetron + Chewing gum | Combination Product | Ondansetron 4 mg IV push Peppermint sugar free chewing gum |
|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |