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Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT03297021
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Katz, Icahn School of Medicine at Mount Sinai

Brief Summary:
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Condition or disease Intervention/treatment Phase
Post-operative Nausea and Vomiting Drug: Ondansetron 4 MG Drug: Ondansetron 8mg Phase 4

Detailed Description:
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
Primary Purpose: Prevention
Official Title: Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Ondansetron 4mg Pre-emergence Drug: Ondansetron 4 MG
dose as per arm selection

Experimental: Ondansetron 8mg Pre-emergence Drug: Ondansetron 8mg
dose as per arm selection

Experimental: Ondansetron Pre-Incision and Pre-emergence
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Drug: Ondansetron 4 MG
dose as per arm selection




Primary Outcome Measures :
  1. Incidence of Post-operative nausea and vomiting [ Time Frame: average of 4 hours ]
    Incidence of Post-operative nausea and vomiting prior to discharge from PACU


Secondary Outcome Measures :
  1. Episodes of vomiting in the PACU [ Time Frame: average of 4 hours ]
  2. Presence of nausea or vomiting on post-operative day one [ Time Frame: Day 1 ]
  3. Number of additional treatments needed to control nausea or vomiting in the PACU [ Time Frame: average of 4 hours ]
  4. Time to discharge from PACU [ Time Frame: average of 4 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion Criteria:

  • Patients with allergies or contraindications to study medications

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): NCT03297021


Contacts
Contact: Daniel Katz, MD 212-241-7475 Daniel.katz@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Daniel Katz, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Daniel Katz, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03297021     History of Changes
Other Study ID Numbers: GCO 17-1618
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Daniel Katz, Icahn School of Medicine at Mount Sinai:
ambulatory surgery
post-operative nausea and vomiting
general anesthesia

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
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