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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02143531 |
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Date of registration:
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15/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
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Scientific title:
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Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02143531 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Marie Aouad, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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American Univesity of Beirut Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 18-80
- ASA class I, II, and III
- undergoing elective surgery under general anesthesia
Exclusion Criteria:
- Patients with history of arrhythmias, QTc prolongation or allergies to the study
drugs will be excluded from the study.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Nausea and Vomiting
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Intervention(s)
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Drug: 4 mg of Ondansetron IV
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Drug: 1mg of Haloperidol IV
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Primary Outcome(s)
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The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
[Time Frame: during the first hour postoperatively]
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Secondary Outcome(s)
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Rescue anti-emetic
[Time Frame: during the first 24 hours postoperatively]
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Patient satisfaction
[Time Frame: 24 hours after surgery]
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Side effects in PACU
[Time Frame: 1 hour postoperatively]
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Recurrence of postoperative nausea and vomiting (PONV)
[Time Frame: during first 24 hours postoperatively]
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Severity of postoperative nausea and vomiting (PONV)
[Time Frame: during the first 24 hours postoperatively]
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Secondary ID(s)
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ANES.MA 09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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