Assessment of the trachea extubation in the operation room after open heart surgery with cardiopulmonary bypass using various anesthesia screening compared with conventional extubation in intensive care unit
Design
This is a single-blinded clinical trial. 100 eligible patients were allocated in two groups by simple randomization: one group received conventional extubation in the intensive care unit and the other underwent extubation in the operation room. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
This single-blinded randomized clinical trial was conducted in Rajaie Cardiovascular Medical and Research Center. For blinding, patients were unaware of the group they were allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18-65 years of age
BMI≥18-25 kg/m2
LVEF>35%
Without history of myocardial infarction during the last seven days
Not having COPD
Emphysema
Not receiving potent inhalation drugs
Exclusion criteria:
Receiving inotropes for hemodynamic support before operation
Needing reoperation due to surgical adverse outcomes like bleeding
Not cooperating during the first days after operation
Intervention groups
Group one: trachea extubation in the intensive care unit
Group two: trachea extubation in the operation room
Main outcome variables
Arterial blood gas analysis; systolic and diastolic blood pressure; heart rate; inotrope need; amount of anesthetics use; blood and transfusion products
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161220031487N7
Registration date:2018-03-14, 1396/12/23
Registration timing:retrospective
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
Assessment of the Trachea extubation in the operation room in open heart surgery with cardiopulmonary bypass using various anesthesia monitoring
Public title
Effects of anesthesia monitoring on trachea extubation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective coronary artery bypass grafting operation
Body mass index of 18-25 kg/m2
LVEF>35%
Exclusion criteria:
Receiving inotropes for hemodynamics support before operation
Needing reoperation due to surgery-related complications such as bleeding
Not cooperating in the early post-operative days
Myocardial Infarction in the 7 recent days
Emphysema
Needing reoperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using excel software and random number assignment with concealment of allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are unaware of the group they are allocated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Hemmat highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1416771818
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.IUMS.FMD.REC 1396.06818767611
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Intensive care unit entrance
Method of measurement
Barometer and vital sign monitoring device
2
Description
Use of anesthetics
Timepoint
During operation
Method of measurement
Calculating and registering the amount of the medication used
3
Description
Using inotropes
Timepoint
In operation room and in ICU
Method of measurement
Calculating and registering the amount of medication used.
4
Description
Diastolic blood pressure
Timepoint
Intensive care unit entrance
Method of measurement
Barometer and vital sign monitoring device
5
Description
Heart rate
Timepoint
Intensive care unit entrance
Method of measurement
Vital sign monitoring device
Secondary outcomes
1
Description
Arterial blood gas analysis
Timepoint
Before anesthesia induction and on intensive care unit entrance
Method of measurement
Blood gas analysis device
Intervention groups
1
Description
Intervention group: trachea extubation in the operation room- The nature of this intervention is the use of short-acting drugs and multiple anesthetic monitoring, and muscle and cardiovascular relaxation in patients with open heart surgery with cardiopulmonary bypass, in order to maintain adequate depth of anesthesia and maintain stable hemodynamics. At the end of the anesthesia, with neutralizing the effect of medications and maintaining the adequate analgesia and hemodynamic stability, and to ensure adequate surgical homeostasis, the patient is extubated in the operation room and transferred to the ICU.
Category
Treatment - Other
2
Description
Control group: extubation in the intensive care unit- The patient receives the usual anesthetic, and after transfer to the intensive care unit, the condition of the tracheal tube is sustained until the hemodynamic stability, and mechanical ventilation is performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Ziae Totonchi
Street address
Niyayesh Exp., Valiasr cross.
City
Tehran
Province
Tehran
Postal code
1416771818
Phone
+98 21 2392 4714
Email
ziya189@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Malekouti
Street address
Next to Milad Tower, Hemmat Exp.,
City
Tehran
Province
Tehran
Postal code
1416771818
Phone
+98 21 8674 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ziya Totonchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Niyayesh Exp., Valiasr cross.
City
Tehran
Province
Tehran
Postal code
1416771818
Phone
+98 21 2392 4714
Email
ziy149@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ziae Totonchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Niyayesh Exp., Valiasr cross.
City
Tehran
Province
Tehran
Postal code
1416771818
Phone
+98 21 2392 4714
Email
ziya189@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ziae Totonchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Niyayesh Exp., Valiasr cross.
City
Tehran
Province
Tehran
Postal code
1416771818
Phone
+98 21 2392 4714
Email
ziya189@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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