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Effect of Ramosetron on Post-discharge Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT03409835
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

Brief Summary:
Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Condition or disease Intervention/treatment Phase
Hysteroscopy Drug: Ramosetron Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramosetron Drug: Ramosetron
Ramosetron 0.3 mg is administered after induction of general anesthesia.

Placebo Comparator: Control Drug: Normal saline
Normal saline 2 ml is administered after induction of general anesthesia.




Primary Outcome Measures :
  1. The change in the occurrence of postoperative nausea [ Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour ]
  2. The change in the occurrence of postoperative vomiting [ Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour ]

Secondary Outcome Measures :
  1. The change of postoperative pain score [ Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour ]
    Score range is from 0 to 10.

  2. The change in the number of postoperative administration of rescue analgesic drug [ Time Frame: Postoperative 30 minute and 3 hour ]
  3. The change in the number of postoperative administration of rescue antiemetic drug [ Time Frame: Postoperative 30 minute and 3 hour ]
  4. The change of patient's satisfaction score [ Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour ]
    Score range is from 0 to 10.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

Exclusion Criteria:

  • American Society of Anesthesiologists physical statue 3 or more
  • Planned admission after surgery
  • Intravenous anesthesia
  • During chemotherapy
  • Pregnancy or breastfeeding
  • Abnormal liver or kidney function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409835


Contacts
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Contact: Hyo-Seok Na 1087012913 hsknana@gmail.com

Locations
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Korea, Republic of
Seoul National Univ. Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Hyo-Seok Na    1087012913    hsknana@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Hyo-Seok Na, Principle investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03409835     History of Changes
Other Study ID Numbers: PDNV
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action