The effect of correct application education of anesthesia and surgery safety checklists on discharge from recovery in patients undergoing orthopedic surgery by general anesthesia in Imam Khomeini Treatment and Educational center of Urmia in 2017
Study of Aldrete criteria using anesthesia safety checklist on discharge of recovery in patients undergoing orthopedic surgery by general anesthesia
Design
Clinical trials with control groupو parallel groups trial with convenience sampling
Settings and conduct
This clinical trial was conducted with control groups, parallel groups that patients requiring orthopedic surgery under general anesthesia were included in the study. Blinding did not take place.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elective orthopedic surgery in upper and lower extremities, Use of general anesthesia (up to 2 hours), Age range between 20 to 60 years, Non-substance abuse
Exclusion criteria: Acute hemorrhage patients with cardiac emergencies
Intervention groups
Education of Aldrete discharge criteria checklist
Main outcome variables
Aldrete score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151205025366N19
Registration date:2018-06-17, 1397/03/27
Registration timing:retrospective
Last update:2018-06-17, 1397/03/27
Update count:0
Registration date
2018-06-17, 1397/03/27
Registrant information
Name
Rahim Baghaei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4916
Email address
rbaghaei@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-03-22, 1397/01/02
Trial completion date
empty
Scientific title
The effect of correct application education of anesthesia and surgery safety checklists on discharge from recovery in patients undergoing orthopedic surgery by general anesthesia in Imam Khomeini Treatment and Educational center of Urmia in 2017
Public title
The effect of correct application education of anesthesia and surgery safety checklists on on discharge from recovery in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective orthopedic surgery in upper and lower extremities
Use of general anesthesia (up to 2 hours)
Age range between 20 to 60 years
Non-substance abuse
Exclusion criteria:
Acute hemorrhage
patients with cardiac emergencies
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
334
Actual sample size reached:
334
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334) University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-07-13, 1396/04/22
Ethics committee reference number
Ir.umsu.rec.1396,173.
Health conditions studied
1
Description of health condition studied
Adult respiratory distress syndrome
ICD-10 code
J80
ICD-10 code description
Adult respiratory distress syndrome
Primary outcomes
1
Description
Aldrete score
Timepoint
Entrance to recovery, first 15 minutes, second 15 minutes second, Third 15 minutes , fourth 15 minutes and exit of recovery
Method of measurement
Aldrete checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Education of Aldrete recovery discharge criteria
Category
Diagnosis
2
Description
Control group: Without specific education
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Urmia
Full name of responsible person
Rahim Baghaei
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334) University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 3000
Email
rbaghaei@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Deputy research of University
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334) University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
rbaghaei@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Baghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Urmia University of Medical Sciences, 11th km of Sarv road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4916
Fax
+98 44 3275 4921
Email
rbaghaei@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
baghaei rahim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nazlou .nursing and midwifery univercity
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4918
Fax
Email
rbaghaei2001@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Baghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Urmia University of Medical Sciences, 11th km of Sarv road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4916
Fax
+98 44 3275 4921
Email
rbaghaei@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared for research purposes.
When the data will become available and for how long
After six months
To whom data/document is available
Students and professors of university
Under which criteria data/document could be used
Providing unanimous data
From where data/document is obtainable
Send email to me
What processes are involved for a request to access data/document