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The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen
After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).
The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Experimental | Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg |
|
| Placebo | Placebo Comparator | Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | 80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale | 0 postoperative hours |
| Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 6 postoperative hours |
| Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 12 postoperative hours |
| Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 24 postoperative hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Tlahuac | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38429485 | Derived | Ortiz E, Gonzalez AI, Jaime V, Guzman JA, Esparza I, Orozco JO, Guerrero MA, Ramos A, Zerrweck C. The impact of Aprepitant on Nausea and Vomiting following Laparoscopic Sleeve Gastrectomy: A Blinded Randomized Controlled Trial. Obes Surg. 2024 Apr;34(4):1316-1323. doi: 10.1007/s11695-024-07129-0. Epub 2024 Mar 2. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting
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Triple-blinded, 1:1ratio to Aprepitant or placebo
| Placebo | Other | Placebo + standard antiemetic regimen, once two hours before surgery |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |