NCT02849483

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

July 27, 2016

Last Update Submit

January 11, 2017

Conditions

Postoperative Nausea and Vomiting

Keywords

PONVdigestive signs and symptomsvomitingantiemeticsnausearamosetron

Outcome Measures

Primary Outcomes (1)

  • Time from surgery to the passage of first flatus

    Within 10 days after surgery

Secondary Outcomes (2)

  • Time to first defecation

    Within 10 days after surgery

  • Incidence of postoperative ileus

    Within 10 days after surgery

Other Outcomes (2)

  • 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

Study Arms (2)

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)

Drug: Ramosetron

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

Drug: Normal saline

Interventions

RamosetronDRUG

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.

Also known as: Nasea
Ramosetron
Normal salineDRUG

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.

Control

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age
  • ASA(American Society of Anesthesiologists) physical status class I or II
  • Scheduled for gynecological laparoscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 02447, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34614204DERIVED

MeSH Terms

Conditions

Postoperative Nausea and VomitingSigns and Symptoms, DigestiveVomitingNausea

Interventions

ramosetronSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mi Kyeong Kim, M.D., Ph.D.

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngsoon Kim, M.D., Ph.D.

CONTACT

+82-958-8589ys.kim@khu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

KR(1)