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The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.
Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O-4PI | 4 mg Ondansetron given Pre-Induction |
| |
| O-8PI | 8 mg Ondansetron given Pre-Induction |
| |
| O-4PE | 4 mg Ondansetron given Pre-Emergence |
| |
| O-8PE | 8 mg Ondansetron given Pre-Emergence |
| |
| D-4PI | 4 mg Dexamethasone given Pre-Induction |
| |
| D-8PI | 8 mg Dexamethasone given Pre-Induction |
| |
| D-4PE | 4 mg Dexamethasone given Pre-Emergence |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parallel Assignment | Other | Prospective, Triple blinded, randomized, controlled trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of postoperative nausea and/or vomiting | Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective surgery under general anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AbdulRhman MA Ibnouf, MBBS | Contact | +962786468830 | ibnouf@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| AbdulRhman MA Ibnouf, MBBS | Anaesthesia Department, Jordan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan Hospital | Recruiting | Amman | 11152 | Jordan |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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|
| D-8PE | 8 mg Dexamethasone given Pre-Emergence |
|
| O-4PI+D-8PI | 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction |
|
| O-4PI+D-8PE | 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence |
|
| O-4PE+D-8PI | 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction |
|
| O-4PE+D-8PE | 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence |
|
| Placebo Group | 2 ml Saline 0.9% |
|
| D012816 | Signs and Symptoms |