Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Ramosetron
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-70 yrs of age ASA(American Society of Anesthesiologists) physical status class I or II Scheduled for gynecological laparoscopic surgery Exclusion Criteria: Allergic to study drugs Antiemetics or steroids use within 24 hrs prior to surgery Dependence upon opioids Insulin dependent Diabetes Mellitus Cardiovascular or pulmonary disease Renal or hepatic insufficiency BMI>=35kg/m2 History of motion sickness or PONV Cigarette smoker Conversion to open laparotomy from laparoscopic surgery Pregnants

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramosetron<br>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) | Drug: Ramosetron<br>* 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.<br>* Other names: Nasea;|
| Placebo Comparator: Control<br>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 | Drug: Normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from surgery to the passage of first flatus |  | Within 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first defecation |  | Within 10 days after surgery | 
| Incidence of postoperative ileus |  | Within 10 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, digestive signs and symptoms, vomiting, antiemetics, nausea, ramosetron