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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 1, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date February 12, 2019
Study Start Date  ICMJE September 7, 2015
Actual Primary Completion Date April 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
incidence of nausea and vomiting [ Time Frame: 24 hours after administration of study drug ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Mass
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Ondansetron group
    Intervention: Drug: Ondansetron
  • Experimental: Ramosetron group
    Intervention: Drug: Ramosetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2019)
80
Original Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
210
Actual Study Completion Date  ICMJE April 2, 2016
Actual Primary Completion Date April 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03017222
Other Study ID Numbers  ICMJE 4-2015-0435
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP