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| Name | Class |
|---|---|
| AHEPA University Hospital | OTHER |
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Protocol title: Role of low dose droperidol in postoperative vomiting
Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery
Design: Prospective, randomized, placebo-controlled study
Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy
No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll
Duration of Treatment: Prior operation
Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively
Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery
In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo Administrated 30min prior to operation |
|
| B | Experimental | 0.625 mg Droperidol administrated i.v 30 min prior surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droperidol | Drug | 0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vomiting episodes | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Light nausea | 24 hours | |
| Control of nausea | 24 hours | |
| Anti-vomiting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaak Kesisoglou | Associate Professor in Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Department of Surgery, AHEPA University Hospital | Thessaloniki | Macedonia | 55236 | Greece | ||
| 3rd Department of Surgery, AHEPA University Hospital |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004329 | Droperidol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
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| Saline solution |
| Drug |
Saline solution administrated i.v 30 min prior surgery |
|
| 24 hours |
| Adverse events | 24 hours |
| Modification of electrocardiograph | 24 hours |
| Thessaloniki |
| 55236 |
| Greece |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |