Determination of the effect of albuterol spray-on hypoxia and bronchospasm in patients with chronic obstructive pulmonary disease (COPD) under general anesthesia
Design
Participants in the study were assigned to the intervention (B) and control (A) groups by block randomization. In this way, using a dice that has 6 faces, the samples are assigned to their groups. A number is written on each side and each number is assigned to one of the blocks of the table, which has its own special mode. it shows. Group A (albuterol) and group B (no albuterol).
Settings and conduct
Operating room of 5 Azar Hospital in Gorgan
Participants/Inclusion and exclusion criteria
The patient is a smoker, ASA class 1 and 2
The disease is more than 35 years old
The patient has a history of COPD
Intervention groups
Intervention group: The patient receives 2 puffs of albuterol spray (2.5 micrograms per puff) 20 minutes before anesthesia
Main outcome variables
Wheezing
Bronchospasm
Frequent coughing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170108031818N1
Registration date:2021-11-29, 1400/09/08
Registration timing:registered_while_recruiting
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
fatemeh mehravar
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 893 7199
Email address
mehravar10261@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of albuterol spray-on hypoxia and bronchospasm in patients with chronic obstructive pulmonary disease (COPD) under general anesthesia
Public title
The effect of albuterol spray on hypoxia and bronchospasm in patients with chronic obstructive pulmonary disease (COPD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a smoker
ASA is class 1 and 2
The patient has a history of COPD
Exclusion criteria:
The patient develops bronchospasm during the operation
The surgery lasted more than 3 hours
Pulmonary artery pressure is greater than 25 mm Hg
Changes in blood pressure, heart rate and drop in severity by 20% of baseline
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study were assigned to the intervention (B) and control (A) groups by block randomization. In this way, using a dice that has 6 faces, the samples are assigned to their groups. A number is written on each side and each number is assigned to one of the blocks of the table, which has its own special mode. it shows. Group A (albuterol) and group B (no albuterol).
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study is double-blinding. So that both the patient did not know in which treatment group and the investigator (Investigator) were not aware of the patient's treatment group. The method of blinding was such that the esteemed supervisor filled the contents of the spray and the sprays were given to the anesthesia resident student who was the main presenter of the current dissertation. The evaluator, who was a resident student, did not know the contents of the sprays.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
shastkola blv. gorgan
City
gorgan
Province
Golestan
Postal code
4915789465
Approval date
2021-10-03, 1400/07/11
Ethics committee reference number
IR.GOUMS.REC.1400.272
Health conditions studied
1
Description of health condition studied
Chronic pulmonary obstruction(COPD)
ICD-10 code
J44. 9
ICD-10 code description
J44. 9
Primary outcomes
1
Description
wheezing
Timepoint
once. After intubation of the endotracheal tube
Method of measurement
Using a medical earphone, the patient's lungs can be heard
2
Description
Frequent coughing
Timepoint
2 times - before anesthesia and after ecstasy
Method of measurement
By observing the appearance of the patient
3
Description
Bronchospasm
Timepoint
1 time. After anesthesia
Method of measurement
If the patient is intubated, bronchospasm is suspected by the anesthesia ventilator storage bag if the storage bag tightens and is considered positive and recorded.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient receives 2 puffs of albuterol spray (2.5 micrograms per puff) 20 minutes before anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5AZAR HOSPITAL iN GORGAN
Full name of responsible person
Mohrokh Maddah
Street address
5 Azar St., Gorgan
City
gorgan
Province
Golestan
Postal code
4915789465
Phone
+98 17 3217 7419
Email
mehravar10261@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
mahrokh maddah
Street address
5 Azar St., Gorgan
City
gorgan
Province
Golestan
Postal code
4915789465
Phone
+98 17 3217 7419
Email
mehravar10261@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
mahrokh maddah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar St., Gorgan
City
gorgan
Province
Golestan
Postal code
4915789465
Phone
+98 17 3217 7419
Email
mehravar10261@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
mahrokh maddah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5 Azar St., Gorgan
City
gorgan
Province
Golestan
Postal code
4915789465
Phone
+98 17 3217 7419
Email
mehravar10261@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
seyed mahrokh maddah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5azar street
City
gorgan
Province
Golestan
Postal code
4915789465
Phone
+98 17 3217 7419
Email
Mehravar10261@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available