Clinical trial NCT02849483: Effect of Ramosetron on Bowel Motility After Gynecological Surgery
Official title: Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
digestive signs and symptoms
vomiting
antiemetics
nausea
ramosetron
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from surgery to the passage of first flatus
timeFrame: Within 10 days after surgery
Secondary outcomes:
measure: Time to first defecation
timeFrame: Within 10 days after surgery
measure: Incidence of postoperative ileus
timeFrame: Within 10 days after surgery
Other outcomes:
measure: Incidence and severity of postoperative nausea
timeFrame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery
measure: Incidence and severity of postoperative vomiting
timeFrame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyunghee University Medical Center
name: Mi Kyeong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.