Comparison of different doses of granisetron plus dexamethasone versus ondansetron plus dexamethasone in prevention of postoperative nausea and vomiting in patients undergoing tympanoplasty
Patients will randomly allocated in three groups: 1) granisetron 0.1 mg plus dexamethasone 8 mg, 2) granisetron 0.3 mg plus dexamethasone and 3) ondansetron 4 mg plus dexamethasone 8 mg. All patients will receive same premedication with midasolam and fentanyl. Induction of anesthesia will be with propofol and lidocain and muscle relaxation with atracurium. Immediately after intubation , dexamethason 8 mg will adminster to all patients. isofluran will use during anesthesia. 15 minute before tracheal extubation patients will receive 0.1 , 0.3 gransetron or 4mg ondansetron in 2ml syringes by anesthesiologist who blind about patients, group and drugs. Then the patients will follow up for post operative nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207223915N7
Registration date:2012-07-25, 1391/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different doses of granisetron plus dexamethasone versus ondansetron plus dexamethasone in prevention of postoperative nausea and vomiting in patients undergoing tympanoplasty
Public title
comparing different drugs in prevention of post-tympanoplsty nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht Street. Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
54/29176
Health conditions studied
1
Description of health condition studied
post tympanoplasty nausea and vomiting
ICD-10 code
Y83.8
ICD-10 code description
Other surgical procedures
Primary outcomes
1
Description
post operative nausea and vomiting
Timepoint
every 0-2 hours till 24 hours
Method of measurement
clinical monitoring
Secondary outcomes
1
Description
need for anti emetic drugs
Timepoint
every 0-2 hours till 24 hours
Method of measurement
Bellville score
Intervention groups
1
Description
dexamethasone 8 mg IV immediately after intubation for all patients plus
granisetron 0.1 mg 15 minutes before extubation in group A
Category
Treatment - Drugs
2
Description
granisetron 0.3 mg 15 minutes before extubation plus post intubation dexamethasone in group B
Category
Treatment - Drugs
3
Description
Ondansetron 4mg 15 minutes before extubation in addition to post intubation dexamethasone in group C
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Immam Reza Hospital
Full name of responsible person
Ali peirovifar
Street address
Operation room. Immam Reza Hospital.Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research VICE chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Golgasht Street. Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research VICE chancellor of 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
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Perovifar
Position
Associate professor of Anesthesiology
Other areas of specialty/work
Street address
Operation room. Immamm Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate professor of Anesthesiology
Other areas of specialty/work
Street address
Operation room. Immam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)