Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

NCT01806948

Postoperative Nausea and Vomiting

COMPLETED PHASE2

Effect of Ramosetron on Post-discharge Nausea and Vomiting

NCT03409835

Hysteroscopy

UNKNOWN NA

Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

NCT02011659

Uterine Myoma, Ovary Neoplasm, Adenomyosis

UNKNOWN PHASE3

Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

NCT04297293

Day Surgery

UNKNOWN PHASE4

Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

NCT01476280

Postoperative Nausea and Vomiting

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ramosetron

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)

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

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.

Control

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nasea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No