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The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Patients receiving acupuncture at P6 point plus physiological saline solution |
|
| B | Active Comparator | Patients receiving ondansetron plus sham acupuncture |
|
| C | Other | Patients receiving ondansetron plus acupuncture at P6 point |
|
| D | Placebo Comparator | Patients receiving physiological saline solution plus sham acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other |
| ||
| Ondansetron |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea and vomiting | 24 postoperative hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Germano De Cosmo, MD | Catholic University of Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D007093 | Imidazoles |
| D001393 | Azoles |
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|
| Physiological saline solution | Drug |
|
| Sham acupuncture | Other |
|
| Ondansetron | Drug |
|
| Acupuncture at P6 point | Other |
|
| Physiological saline solution | Drug |
|
| Sham acupuncture | Other |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |