Determining and comparing the effect of 0.2 and 0.4 mg/kg of intravenous labetalol on the cardiovascular response to tracheal extubation
Design
This study is a randomized double blinded clinical trial with control group Which is performed on 72 patients who are candidates for elective surgery.
The permutation block method is used for randomization.
Settings and conduct
Study place: Al-Zahra Hospital in Isfahan؛ Type of blindness: double blinded؛ method of blindness: The patient and the observer who collects the information will be unaware of the drug grouping؛ method: On about 72 patients (24 in each group) who are candidates for elective surgery in Al-Zahra Hospital 0.2, 0.4 mg/kg doses of intravenous labetalol and normal saline will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normotensive patients who are candidates for elective surgery less than two hours under general anesthesia requiring endotracheal intubation؛ age between 20 to 60 years؛ ASA one and two؛ informed consent to participate in the study؛ weight 55 to 45 kilogram. Exclusion criteria: pregnant women؛ diabetic patients؛ Patients with uncontrolled underlying cardiovascular disease؛ Baseline heart rate less than 60 beats per minute and systolic blood pressure less than 90 mm Hg؛ Patients with cerebrovascular diseases؛ contraindication of the use of study drugs؛ known allergy to anesthesia drugs of the study؛ opioid abuse؛ Taking drugs with cardiovascular effects
Intervention groups
Intervention group 1: Labetalol (0.2 mg/kg diluted with 0.9% saline to 5 ml)
Intervention group 2: Labetalol (0.4 mg/kg diluted with 0.9% saline to 5 ml)
Control group: 5ml saline 0.9%
Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation
Public title
Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normotensive patients who are candidates for elective surgery less than two hours under general anesthesia requiring endotracheal intubation
Age between 20 to 60 years
ASA one and two
Informed consent to participate in the study
Weight 55 to 85 kilogram
Exclusion criteria:
Pregnant women
Diabetic patients
Patients with uncontrolled underlying cardiovascular disease
Baseline heart rate less than 60 beats per minute and systolic blood pressure less than 90 mmHg
Patients with cerebrovascular diseases
Contraindication of the use of study medicines
Known allergy to anesthetics in the study
Opioid abuse
Taking medicines with cardiovascular effects
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
By using a list of random numbers generated by computer, patients are assigned to each three groups based on the permutation blocks method with blocks with a volume of 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the observer who collects the information will be unaware of the drug grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Blvd, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-17, 1399/07/26
Ethics committee reference number
IR.MUI.MED.REC.1399.633
Health conditions studied
1
Description of health condition studied
Tracheal Extubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before extubation and 1, 3, 5 and 10 minutes after extubation
Method of measurement
Barometer
2
Description
Diastolic blood pressure
Timepoint
Before extubation and 1, 3, 5 and 10 minutes after extubation
Method of measurement
Barometer
3
Description
Pulse rate
Timepoint
Before extubation and 1, 3, 5 and 10 minutes after extubation
Method of measurement
Pulse oximetry
4
Description
Oxygen saturation percentage
Timepoint
Before extubation and 1, 3, 5 and 10 minutes after extubation
Method of measurement
Pulse oximetry
5
Description
Mean arterial pressure
Timepoint
Before extubation and 1, 3, 5 and 10 minutes after extubation
Method of measurement
Barometer
Secondary outcomes
1
Description
Duration of staying in recovery
Timepoint
Based on minutes from arrival to reaching the modified aldrete score of 9
Method of measurement
Information collection form
2
Description
Adverse airway response
Timepoint
During the time of staying in recovery
Method of measurement
Information collection form
3
Description
Hemodynamic complications
Timepoint
During the time of staying in recovery
Method of measurement
Information collection form
4
Description
Duration of extubation
Timepoint
Based on minutes from the time of discontinuing anesthetics to the time of extubation
Method of measurement
Information collection form
Intervention groups
1
Description
Intervention group 1: In this group Syringe containing Labetalol (0.2 mg/kg diluted with 0.9% saline to 5 ml) will be injected.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group Syringe containing Labetalol (0.4 mg/kg diluted with 0.9% saline to 5 ml) will be injected.
Category
Treatment - Drugs
3
Description
Control group: In this group Syringe containing 5 ml of 0.9% saline will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Al-Zahra Hospital; Sofe bolevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghju javanmard
Street address
Vice chancellor of research and technology of university.Isfahan University of Medical Sciences. Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital; Sofe bolevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidraza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital; Sofe bolevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital; Sofe bolevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
hamidshetabi@med.mui.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Unidentifiable individual data including hemodynamic indices and complications in all three groups can be shared.
When the data will become available and for how long
6 months after publication of paper
To whom data/document is available
Academic and medical researchers
Under which criteria data/document could be used
Use for research and treatment purposes
From where data/document is obtainable
Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir
Dr Hamidreza Shetabi
What processes are involved for a request to access data/document
If possible, it will be sent via email up to a maximum of 1 month after applying.