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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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11 April 2016 |
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Main ID: |
NCT02525848 |
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Date of registration:
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14/08/2015 |
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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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Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
PONV |
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Scientific title:
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Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02525848 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Hala S Abdel-Ghaffar, 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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Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
• ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic
gynacological surgeries under general anesthesia.
Exclusion Criteria:
- Central or peripheral neurological pathologies.
- History of drug abuse, chronic pain, or psychiatric disorders.
- Pregnant women
- Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of
operation.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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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: dexamethasone
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Drug: Aprepitant
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Drug: Gabapentin
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Primary Outcome(s)
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incidence (%) of postoperative nausea and vomiting
[Time Frame: 24 hours postoperative]
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Secondary Outcome(s)
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non invasive blood pressure
[Time Frame: intra-operative from induction of general anesthesia till end of surgery.]
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heart rate
[Time Frame: Intra-operative from induction of anesthesia till end of surgery.]
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side effects
[Time Frame: 24 h postoperative.]
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Secondary ID(s)
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IRB00008718/ reference no. 104
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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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