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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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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201207223915N7 |
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Date of registration:
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2012-07-25 |
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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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comparing different drugs in prevention of post-tympanoplsty nausea and vomiting
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Scientific title:
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Comparison of different doses of granisetron plus dexamethasone versus ondansetron plus dexamethasone in prevention of postoperative nausea and vomiting in patients undergoing tympanoplasty |
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Date of first enrolment:
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2011-03-06 |
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Target sample size:
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160 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/4059 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Ali Peirovifar
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Address:
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Operation room. Immam Reza Hospital
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1334 7054 |
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Email:
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peirovifara@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Name:
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Ali Perovifar
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Address:
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Operation room. Immamm Reza Hospital
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1334 7054 |
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Email:
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peirovifara@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: patients that are candidate for tympanoplasty with ASA class I or II and age 15-60 year.
Exclusion criteria: gastrointestinal diseases, history of treatment with anti emetics or drugs with anti emesis effects at 24 hours before surgery, BMI more than 36.5, pregnant or lactating mothers, opiate abuse, sensitivity reaction to studied drugs.
Exclusion criteria:
Age minimum:
15 years
Age maximum:
60 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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post tympanoplasty nausea and vomiting.
Other surgical procedures
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Other surgical procedures
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Intervention(s)
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granisetron 0.3 mg 15 minutes before extubation plus post intubation dexamethasone in group B
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Ondansetron 4mg 15 minutes before extubation in addition to post intubation dexamethasone in group C
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dexamethasone 8 mg IV immediately after intubation for all patients plus
granisetron 0.1 mg 15 minutes before extubation in group A
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Intervention 1: dexamethasone 8 mg IV immediately after intubation for all patients plus
granisetron 0.1 mg 15 minutes before extubation in group A. Intervention 2: granisetron 0.3 mg 15 minutes before extubation plus post intubation dexamethasone in group B. Intervention 3: Ondansetron 4mg 15 minutes before extubation in addition to post intubation dexamethasone in group C.
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Treatment - Drugs
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Primary Outcome(s)
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Post operative nausea and vomiting. Timepoint: every 0-2 hours till 24 hours. Method of measurement: clinical monitoring.
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Secondary Outcome(s)
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Need for anti emetic drugs. Timepoint: every 0-2 hours till 24 hours. Method of measurement: Bellville score.
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Source(s) of Monetary Support
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Research VICE chancellor of Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethic Committee of Tabriz University of Medical Sciences
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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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