Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery

Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.

Study Overview

• Status: Completed
• Conditions: Abdominal Mass
• Intervention / Treatment: Drug: Ondansetron; Drug: Ramosetron

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 19-65 years
• patients undergoing elective laparoscopic surgery under inhalational anesthesia
• duration of surgery between 30 min to 4 h
• ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors
• female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids.

Exclusion Criteria:

• patients with history of being allergic to 5-HT3 receptor antagonist
• patients with history of anticancer chemotherapy
• chronic opioids use, alcohol abuse, or drug abuse
• patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery
• presence of renal (serum Cr > 1.6 mg/dl)
• hepatic(liver enzymes more than 2 times normal value) insufficiency
• patients converted to open laparotomy
• patient who are pregnant or breast-feeding
• patient with borderline QTc(corrected QT interval) prolongation (> 430 ms for male, >450 ms for female)
• patient not able to understand the scoring of pain or express the degree of PONV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ondansetron group	Drug: Ondansetron; Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.
EXPERIMENTAL: Ramosetron group	Drug: Ramosetron; Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of complete response	complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration	24 hours after administration of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of nausea and vomiting	24 hours after administration of study drug

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: September 7, 2015
• Primary Completion (ACTUAL): April 2, 2016
• Study Completion (ACTUAL): April 2, 2016

Study Registration Dates

• First Submitted: January 1, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (ESTIMATE): January 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron; Ramosetron
• Other Study ID Numbers: 4-2015-0435