Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Kyung Hee University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Normal saline; Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02849483

KHUH 2016-05-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

Ramosetron

Experimental group

Description:

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)

Treatment:

Drug: Ramosetron

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline