Completed

NCT Number: NCT03017222

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.

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Key information

Conditions

Abdominal Mass

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

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.

Ramosetron

Drug

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.

Primary outcomes

ratio of complete response

Time frame: 24 hours after administration of study drug

complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration

Secondary outcomes

incidence of nausea and vomiting

Time frame: 24 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 11, 2017
Registry last updated: Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.