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Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment of irritable bowel syndrome. The investigators examine the effect of ramosetron on postoperative bowel motility.
Ramosetron, a new potent and long-acting selective 5-HT3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of diarrhea-predominant irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone, There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramosetron | Experimental | 2 ml of normal saline iv before induction, ramosetron 0.3 mg iv at the end of surgery, ramosetron 0.6 mg added to the iv PCA(Patient-Controlled Analgesia) |
|
| Control | Placebo Comparator | dexamethasone 10 mg iv before induction, 2 ml of normal saline iv at the end of surgery, 4 ml of normal saline added to the iv PCA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron | Drug | Administer 2 ml of normal saline iv before induction. Inject ramosetron 0.3 mg iv at the end of surgery. Add ramosetron 0.6 mg to the iv PCA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from surgery to the passage of first flatus | Within 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first defecation | Within 10 days after surgery | |
| Incidence of postoperative ileus | Within 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of postoperative nausea | 0-6 hours, 6-24 hours, and 24-48 hours after surgery | |
| Incidence and severity of postoperative vomiting | 0-6 hours, 6-24 hours, and 24-48 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youngsoon Kim, M.D., Ph.D. | Contact | +82-958-8589 | ys.kim@khu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Mi Kyeong Kim, M.D., Ph.D. | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Recruiting | Seoul | 02447 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34614204 | Derived | Kang HY, Kim Y, You AH, Kim YJ, Kim MK. A randomized controlled trial of the effect of ramosetron on postoperative restoration of bowel motility after gynecologic laparoscopic surgery. Int J Gynaecol Obstet. 2022 Jul;158(1):172-178. doi: 10.1002/ijgo.13969. Epub 2021 Oct 16. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal saline | Drug | Administer dexamethasone 10 mg iv before induction. Inject 2 ml of normal saline iv at the end of surgery. Add 4 ml of normal saline to the iv PCA. |
|