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Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.
To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.
In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.
Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.
The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.
All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.
Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLACEBO Group | Placebo Comparator | Received normal saline |
|
| DEXAMETHASONE Group | Active Comparator | Received 4 mg Dexamethasone. |
|
| ONDANSETRON | Active Comparator | Received 4 mg Ondansetron |
|
| DEXAMETHASONE + ONDANSETRON | Active Comparator | Received 4mg Dexamethasone + 4mg Ondansetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLACEBO | Drug | received normal saline, intravenously |
| |
| Dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| • Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery | 1-24 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| • Standardized score of nausea and/or vomiting severity if PONV occurs. | 1-24 hours post-operatively | |
| • Pain score during the immediate post-operative period. | 1-24 hours post-operatively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MICHELE REIBALDI, Professor | Contact | +39 0953781291 | mreibaldi@libero.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University | Naples | Italy | 80131 | Italy |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
4 mg, intravenously, at the start of surgery |
|
| Ondansetron | Drug | 4 mg, intravenously, 15 minutes before the end of surgery. |
|
| Dexamethasone + Ondansetron | Drug | 4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery. |
|
| • Number of antiemetic rescue medications given postoperatively. |
| 1-24 hours post-operatively |
| • Rates of known side effects. | 1-24 hours post-operatively |
| University of Sassari | Sassari | Sardinia | Italy |
| University of Catania | Catania | Sicily | 95125 | Italy |
| Polytechnic University of Marche | Ancona | The Marches | Italy |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| 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 |