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This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
. A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(Control group) | No Intervention | include 50 patients scheduled for sleeve gastrectomy | |
| Group 2 | Experimental | which include 50 patients scheduled for sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen Tablets | Drug | 10 mg oral baclofen 1 h before anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of this study will be the complete response | Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy. | The first 48 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum level of vasopressin | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. |
| Change in serum level of substance P | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aya Moussa | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital. | Tanta | 31111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41981586 | Derived | Moussa AG, El-Haggar SM, El-Mahdy TM, Mostafa TM. Efficacy and safety of baclofen in the prophylaxis of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized controlled trial. BMC Surg. 2026 Apr 15;26(1):271. doi: 10.1186/s12893-026-03696-4. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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double blind
| The first 48 hours after surgery. |
| Change in serum level of dopamine | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. |
| Change in serum level of serotonin | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. |
| Change in serum level of tachykinin 1 | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |