Comparisons of hearing results and graft status in myringoplasty surgery in patients with chronic otitis media in the two groups receiving N2O and non receiving N2O during anesthesia in Amir Alam hospital and Valiasr hospital during the year 2013
This study is designed to investigate n2o anesthesia gas effects on graft outcomes in tympanoplasty surgeries.This is an interventional clinical trial. during study patients who are candidate for tympanoplasty procedure will be enrolled in this study. patients with cholestetoma, previous ear surgery, active infection, diabetes mellitus and tympanosclerosis will be exluded. patients are randomly allocated to two groups: anesthesia with N2O 2) anesthesia without n2o. microsurgery method will be the same in all of the patients.
microscopic examination after 3 months post op will reveal graft status. also, post operative audiometry will be used to study patients hearing status.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050110041N3
Registration date:2013-06-12, 1392/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Ali Kouhi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-kouhi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons of hearing results and graft status in myringoplasty surgery in patients with chronic otitis media in the two groups receiving N2O and non receiving N2O during anesthesia in Amir Alam hospital and Valiasr hospital during the year 2013
Public title
Comparisons of hearing results and graft status in myringoplasty surgery in patients with chronic otitis media in the two groups receiving N2O and non receiving N2O during anesthesia in Amir Alam hospital and Valiasr hospital during the year 2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: candidates for tympanoplasty procedure.
Exlusion criteria: cholestetoma; previous ear surgery; active infection; diabetes mellitus and tympanosclerosis.
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
59
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods st.
City
Tehran
Postal code
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
91-04-48-20459-76306
Health conditions studied
1
Description of health condition studied
Chronic otitis media
ICD-10 code
H66.9
ICD-10 code description
Otitis media, unspecified
Primary outcomes
1
Description
Tympanic membrane graft sucess
Timepoint
3 months post operation
Method of measurement
Microscopic examination
Secondary outcomes
1
Description
Hearing
Timepoint
3 months post operation
Method of measurement
Audiometry
Intervention groups
1
Description
Anesthesia without N2O
Category
Treatment - Drugs
2
Description
using N2O during anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehtan University of Meical Sciences-Amir Alam hospital
Full name of responsible person
Dr Ali Kouhi
Street address
Amir-Alam Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nouruz zadeh
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant professor
Other areas of specialty/work
Street address
Amir-Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir-Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir-Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)