Background: Nausea and vomiting after middle ear surgery is one of the most common complications after surgery; considered to become the ground for the incidence of other adverse consequences. The aim of this study was to evaluate the effect of prophylactic intravenous dexamethasone 16 mg on postoperative nausea and vomiting after stapedectomy. Methods: In a randomized double-blind controlled trial study, 70 patients candidate for stapedectomy divided into two equal groups, using the same sedation by single surgeon. While the case group received 16 mg Dexamethasone, half an hour before surgery, the control group received 4ml intravenous saline as a placebo. Patients were controlled 1-24 hours after the surgery in terms of nausea and vomiting and dependent variables such as vertigo and tinnitus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012133181N3
Registration date:2012-02-28, 1390/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-28, 1390/12/09
Registrant information
Name
Zahra Mokhtari
Name of organization / entity
Otorhinolaryngology research center, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
zmokhtari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of dexamethasone on postoperative nausea and vomiting in patients under stapedectomy
Public title
Effect of dexamethasone on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: adult patients undergoing stapedectomy surgery who were referred to ENT clinic of Amiralam hospital and classification of physical status (American society of Anesthesilogist) ASA class I or II component. Exclusion criteria: motion sickness; history of GI disorder; history of diabetes and history of antiemetic drugs to 48 hours before surgery; history of taking corticosteroids, and prior history of PONV during two weeks before.
Age
From 15 years old to 62 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Tehran University of Medical Sciences
Street address
Vice Chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2010-12-18, 1389/09/27
Ethics committee reference number
85-01-48-3532
Health conditions studied
1
Description of health condition studied
Stapedectomy surgery
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
1-24 hour
Method of measurement
observation and questionary
Secondary outcomes
1
Description
vertigo
Timepoint
1-24 hour
Method of measurement
questionary
Intervention groups
1
Description
Dexamethone, 16mg, will be injected intravenously half an hour before surgery.
Category
Prevention
2
Description
4ml normal saline, as placebo, will be injected intravenously half an hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operative room of Amir Alam Hospital
Full name of responsible person
Zahra Mokhtari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Vice Chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
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, Tehran 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
Otorhinolaryngology Research Center,Tehran University of Medical Sciences
Full name of responsible person
Zahra Mokhtari
Position
PhD student of Medical Physiology at Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Amiralam Hospital
City
Tehran
Postal code
Phone
+98 21 6676 0269
Fax
Email
zmokhtari@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Otorhinolaryngology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Zahra Mokhtari
Position
Msc anesthisology
Other areas of specialty/work
Street address
Otorhinolaryngology Research Center, Amiralam Hospital, North Saadi Ave, Enghelab St
City
Tehran
Postal code
6511111457
Phone
+98 21 6676 0269
Fax
+98 21 6676 0269
Email
zmokhtari@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Otorhinolaryngology Research Center,Tehran University of Medical Sciences
Full name of responsible person
Zahra Mokhtari
Position
Msc anesthesiology, Director of otolaryngology Research Center
Other areas of specialty/work
Street address
Otorhinolaryngology Research Center-Amiralam Hospital-North Saadi Ave-Enghelab St- Tehran
City
Tehran
Postal code
6511111457
Phone
+98 21 6676 0269
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)