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

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ClinicalTrials.gov Identifier: NCT03017222
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Mass Drug: Ondansetron Drug: Ramosetron Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 7, 2015
Actual Primary Completion Date : April 2, 2016
Actual Study Completion Date : April 2, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. incidence of nausea and vomiting [ Time Frame: 24 hours after administration of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03017222    
Other Study ID Numbers: 4-2015-0435
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2017
Additional relevant MeSH terms:
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Ondansetron
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents