Comparison of patient extubation in sitting versus supine position after septoplasty operation in 501 AJA hospital.
Design
Prospective randomized Single blinded Clinical trial study with Simple Random Sampling method using black and white cards (each group was 30)
Settings and conduct
After septoplasty operation in patient who admited in 501 aja hospital and treated with same method,
In one group after the end of the operation and returning the strength of the muscles of the patient, they performed extubation of the tracheal tube in the supine position, and in the other group after observing the relaxation of muscle they performed extubation of tube in the sitting position.
Participants/Inclusion and exclusion criteria
Entry requirements: All patients aged 20-60 years and ASA I who come to the 501 Aja city of Tehran from the time of the approval of the plan for septoplasty with general anesthesia and sign a written consent form for the research project.
Conditions of non-arrival: People with ASA in Class III, II and IV, People with bleeding disorder, People with sleep apnea, People with arthritis rheumatoid , especially in the neck area, People with cervical stenosis or disc .
Individuals with a right shunt to the heart of patent foramen ovale (PFO) in their history (Risk of Paradoxical Venous Air Embolism).
Intervention groups
In one group after the end of the operation and returning the strength of the muscles of the patient and relaxing the muscle relaxation, they performed extubation of the tracheal tube in the supine position, and in the other group after observing the cases of muscle strength recovery and relaxation of muscle relaxation and after the condition of the sitting to the bed We act to extol the patient
Main outcome variables
Extubation position
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110103005536N7
Registration date:2020-07-01, 1399/04/11
Registration timing:registered_while_recruiting
Last update:2020-07-01, 1399/04/11
Update count:0
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
Mohamadreza Rafiei
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8933
Email address
mo_rafiei@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-07-07, 1394/04/16
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
2015-07-07, 1394/04/16
Actual recruitment end date
2021-01-09, 1399/10/20
Trial completion date
2021-01-09, 1399/10/20
Scientific title
Comparison of patient extubation in sitting versus supine position after septoplasty operation in 501 AJA hospital.
Public title
Comparison of patient extubation after septoplasty operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patient in 20-60 years old
ASA 1
Exclusion criteria:
patient with ASA II, III, IV
hematologic disorders
cervical rheumatoid arthritis
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to the Simple Random Sampling method using black and white cards (each group was 30), so that patients with a black card to group one, and patients with a white card The second group is dedicated and this process is repeated again.
Blinding (investigator's opinion)
Single blinded
Blinding description
- Patients undergoing anesthesia awake without knowing where they are being exposed.
2. The person collecting the information that is entered into the room after extubation of the patient and does not know how to extubate the patient.
3. The person analyzing the information that is not present in the operating room and only has access to the encoded information and is not aware of how each patient is extubating.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA university of medical sciences
Street address
West Fatemi- Etemadzadeh
City
Tehran
Province
Tehran
Postal code
8158177365
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
IR.AJAUMS.REC.1394.16
Health conditions studied
1
Description of health condition studied
septoplasty
ICD-10 code
J34.2
ICD-10 code description
Deflection or deviation of septum
Primary outcomes
1
Description
Position of extubation
Timepoint
during the intervention
Method of measurement
observation. this parameter evaluates in two position: supine and sitting.
Secondary outcomes
1
Description
systolic blood pressure
Timepoint
during the intervention
Method of measurement
monitoring of patient blood pressure
2
Description
heart rate
Timepoint
during the intervention
Method of measurement
monitoring of patient heart rate
3
Description
Arterial oxygen saturation
Timepoint
during the intervention
Method of measurement
monitoring of patient arterial oxygen saturation
4
Description
Laryngospasm
Timepoint
during the intervention
Method of measurement
clinical
5
Description
Agitation
Timepoint
during the intervention
Method of measurement
Richmond agitation sedation scale (RASS)
6
Description
oral suction
Timepoint
during the intervention
Method of measurement
Count the number of times you need to suction with the device
7
Description
age
Timepoint
before start of intervention
Method of measurement
patient identification card
8
Description
Gender
Timepoint
Before start of intervention
Method of measurement
based on the phenotype
Intervention groups
1
Description
Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "supine" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients.
Category
Treatment - Other
2
Description
Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "sitting" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
501 AJA Hospital
Full name of responsible person
Dr. Mohamadreza Rafiei
Street address
501 AJA hospital, , Etemadzadeh St.,west Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
mo_rafiei@armyums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Saeed Soleyman Meygooni
Street address
Artesh Unuvercity of Medical Sciences, Etemad zadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
mo_rafiei@armyums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Artesh University of Medical Sciences
Full name of responsible person
Dr Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi . Etemadzadeh
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
mo_rafiei@armyums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi , Etemadzadeh
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
rafiei_mohamadreza@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mohamadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi , Etemadzadeh
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
rafiei_mohamadreza@yahoo.com
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
All data can be shared after it is unrecognizable
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
All researchers and colleagues in this field
Under which criteria data/document could be used
For the purpose of therapeutic-research purposes and by mentioning the names of the authors of the article
From where data/document is obtainable
Dr. mohamadreza rafiei
What processes are involved for a request to access data/document