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| ID | Type | Description | Link |
|---|---|---|---|
| CJ_ALX_302 | Other Identifier | CJ Cheiljedang Corporation |
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| Name | Class |
|---|---|
| HK inno.N Corporation | INDUSTRY |
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This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.
Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palonsetron | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response at 24 hr | Complete response means no retching or vomiting and no administration of secondary rescue drug. | at 24 hour after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response at 72 hr | Complete response means no retching or vomiting and no administration of secondary rescue drug. | at 72 hour after randomization |
| Complete control at 72 hr | Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Soo Hahm, MD, PhD | Samsung Seoul Hospital, Samsung Medical Center | Study Director |
| Youn Hong Kim, MD, PhD | Kangpook Samsung Hospital, Samsung Medical Center | Principal Investigator |
| Jung Won Hwang, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Joun Heum Yeon, MD, PhD | Sange Bahk Hospital, Inje School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 135-710 | South Korea | ||
| Bungdang Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25037960 | Derived | Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19. |
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|
| placebo control group | Drug | placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery. |
|
|
| at 72 hour after randomization |
| Complete control at 24 hr | Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug. | at 24 hour after randomization |
| the incidence of nausea, retching, vomiting | the incidence of nausea with numerical rating scale >= 4, retching, vomiting | at 24, 48, 72 hr after randomization |
| Time to recovery of nausea, retching, or vomiting | Time to recovery of nausea, retching, or vomiting from administration of palonosetron | at 24, 48, 72 hr after randomization |
| the severity of nausea | the severity of nausea measured by NRS (numerical rating scale) | at the time of, 24, 48, 72 hour after randomization |
| the incidence of rescue drug use | the incidence of rescue drug use | at 24, 48, 72 hour after randomization |
| QOL by modified Osoba Nausea and Emesis Module | QOL by modified Osoba Nausea and Emesis Module | at 24, 48, 72 hour after randomization |
| Seoul |
| South Korea |
| Kangpook Samsung Hospital | Seoul | South Korea |
| Sangye Bahk Hospital, Inje School of Medicine | Seoul | South Korea |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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