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This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.
Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative nausea and vomiting is concerned the results are still conflicting.
This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimenydrinate | Active Comparator | Preoperative per os administration of 50 mg dimenydrinate |
|
| Ondasentron | Other | Intraoperative intravenous administration of 4 mg ondansetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimenhydrinate Tablets | Drug | 2 hours preoperative per os administration of 50 mg dimenhydrinate |
|
| Measure | Description | Time Frame |
|---|---|---|
| PONV | PONV recording in patients undergone laparoscopic cholocystectomy | 30 minutes postoperative |
| PONV | PONV recording in patients undergone laparoscopic cholocystectomy | 60 minutes postoperative |
| PONV | PONV recording in patients undergone laparoscopic cholocystectomy | 12 hours postoperative |
| PONV | PONV recording in patients undergone laparoscopic cholocystectomy | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative anxiety | preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale | 24 hours before operation |
| preoperative anxiety | preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Arnaoutoglou, MD, PhD | University of Thessaly | Study Chair |
| Konstantinos George Stamoulis, MD, PhD | University Hospital of Larissa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larisa, Department of Anesthesiology | Larissa | Thessaly | Thessaly | Greece |
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| ID | Term |
|---|---|
| D004111 | Dimenhydrinate |
| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Ondansetron iv | Drug | Intraoperative intravenous administration of 4 mg ondansetron |
|
| 30 minutes before operation |
| Awaken time | time from anesthetic drug cessation until extubation | on extubation |
| D001559 |
| Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |