Nausea and vomiting are common complications after anesthesia and surgery. Patients undergoing middle ear surgery are exposed to a higher risk of PONV (Postoperative Nausea & Vomiting). These complications may alter the results of reconstruction and anatomical alignments. Numerous antiemetics have been studied to prevent and treat PONV in patients undergoing middle ear surgeries. The aim of this study is to compare the effect of intravenous Ondansetron and Dexamethasone on these complications.To do this ,In a Double-blind randomized controlled clinical trial 219 patients who undergoing middle ear surgery randomly will be divided into 3 groups (O, D and P) . The patients in group O will be received Ondansetron (4 mg IV), group D patients will be received Dexamethasone (8 mg IV), and group P patients will be received placebo prior to anesthetic induction. Using Bellivelle's scoring system, the incidence of PONV and its severity will be documented during the 24-hour period after surgery and compared between the three groups.The quantitative variables will be compared using one-way ANOVA and a post hoc Tukey test.The comparison of qualitative variables will be performed using contingency tables and chi-squared test as well as Fisher's exact test at p<0.05.
Inclusion criteria : patients undergoing ear surgical operations with physical conditions of ASA I or II
exclusion criteria :Patients with digestive problems, or with a history of treatment with antiemetics and nausea in the last 24 hours and also sever obese patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106154005N4
Registration date:2011-07-04, 1390/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-04, 1390/04/13
Registrant information
Name
Khosro Kolahdouzan
Name of organization / entity
Faculty of Paramedical Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 4777
Email address
kolahdozank@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preoperative Ondansetron and Dexamethasone in prevention of postoperative nausea and vomiting after middle ear surgeries
Public title
Comparison of Ondansetron and Dexamethasone in prevention of nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing ear surgical operations with physical conditions of ASA I or II; Exclusion criteria: Patients with digestive problems, or with a history of treatment with antiemetics and nausea in the last 24 hours and also sever obese patients
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
219
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2009-04-09, 1388/01/20
Ethics committee reference number
1296
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
16-24 hours after operation 8-16 hours after operation 2-8 hours after operation 0-2 hours after operation
Method of measurement
questionnaire
2
Description
Vomiting
Timepoint
16-24 hours after operation 8-16 hours after operation 2-8 hours after operation 0-2 hours after operation
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Before induction of anesthesia, 4 mg of Ondansetron, will be administered intravenously to Ondansetron group respectively. The volume of the drug prescribed will be 3 mL. Premedication will given using Midazolam at a dose of 0.15 mg/kg and Fentanyl at a dose of 1-2µg/kg. Induction will be carried out with Propofol at a dose of 1-2.5 mg/kg and Atracurium at a dose of 0.5 mg/kg. Anesthetic maintenance will be performed using "Total Intravenous Anesthesia" method and also through Propofol at a dose of 10-20 mg/kg/min and Remifentanyl at a dose of 0.5 µg/kg/min.
Category
Treatment - Drugs
2
Description
Before induction of anesthesia, 8 mg of Dexamethasone will be administered intravenously to Dexamethasone group, respectively. The volume of the drug prescribed will be 3 mL in group. Premedication will given using Midazolam at a dose of 0.15 mg/kg and Fentanyl at a dose of 1-2µg/kg. Induction will be carried out with Propofol at a dose of 1-2.5 mg/kg and Atracurium at a dose of 0.5 mg/kg. Anesthetic maintenance will be performed using "Total Intravenous Anesthesia" method and also through Propofol at a dose of 10-20 mg/kg/min and Remifentanyl at a dose of 0.5 µg/kg/min.
Category
Treatment - Drugs
3
Description
Before induction of anesthesia, distilled water will be administered intravenously to placebo group, respectively. The volume of the drug prescribed will be 3 mL in group. Premedication will given using Midazolam at a dose of 0.15 mg/kg and Fentanyl at a dose of 1-2µg/kg. Induction will be carried out with Propofol at a dose of 1-2.5 mg/kg and Atracurium at a dose of 0.5 mg/kg. Anesthetic maintenance will be performed using "Total Intravenous Anesthesia" method and also through Propofol at a dose of 10-20 mg/kg/min and Remifentanyl at a dose of 0.5 µg/kg/min.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahmood Eidi
Street address
Emam Reza Hospital, Daneshgah St. Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
University of Medical Sciences, Daneshghah St, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Eidy
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Faculty of Medicine, University of Medical Sciences, Daneshghah St, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4653
Fax
Email
eidym@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)