Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02849483
• Other study ID #: KHUH 2016-05-201
• Status: Recruiting
• Phase: Phase 4
• First received: July 27, 2016
• Last updated: January 11, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Kyunghee University Medical Center
• Contact: Youngsoon Kim, M.D., Ph.D.
• Phone: +82-958-8589
• Email: ys.kim[@]khu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Ramosetron
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.
• Normal saline
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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of postoperative nausea		0-6 hours, 6-24 hours, and 24-48 hours after surgery	No
Other	Incidence and severity of postoperative vomiting		0-6 hours, 6-24 hours, and 24-48 hours after surgery	No
Primary	Time from surgery to the passage of first flatus		Within 10 days after surgery	No
Secondary	Time to first defecation		Within 10 days after surgery	No
Secondary	Incidence of postoperative ileus		Within 10 days after surgery	No