Protocol summary
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Study aim
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Determining and comparing the effect of 0.1 and 0.2 mg/kg of intravenous labetalol on the cardiovascular response to tracheal extubation
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Design
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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.
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Settings and conduct
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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 0.1, 0.2 mg/kg doses of intravenous labetalol and normal saline will be used.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group 1: Labetalol (0.1 mg/kg diluted with 0.9% saline to 5 ml)
Intervention group 2: Labetalol (0.2mg/kg diluted with 0.9% saline to 5 ml)
Control group: 5ml saline 0.9%
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Main outcome variables
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Systolic blood pressure؛ Diastolic blood pressure؛ Median arterial blood pressure؛ Heart rate؛ O2 saturation
General information
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Reason for update
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Evaluation of the effect of lower doses of labetalol on hematodynamic response to endotracheal tube extubation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180416039326N16
Registration date:
2020-11-30, 1399/09/10
Registration timing:
prospective
Last update:
2022-01-02, 1400/10/12
Update count:
1
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Registration date
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2020-11-30, 1399/09/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-19, 1399/10/30
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Expected recruitment end date
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2021-05-21, 1400/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation
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Public title
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Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patient and the observer who collects the information will be unaware of the drug grouping.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-17, 1399/07/26
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Ethics committee reference number
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IR.MUI.MED.REC.1399.633
Health conditions studied
1
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Description of health condition studied
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Tracheal Extubation
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Systolic blood pressure
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Timepoint
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Before extubation and 1, 3, 5 and 10 minutes after extubation
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Method of measurement
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Barometer
2
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Description
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Diastolic blood pressure
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Timepoint
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Before extubation and 1, 3, 5 and 10 minutes after extubation
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Method of measurement
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Barometer
3
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Description
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Pulse rate
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Timepoint
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Before extubation and 1, 3, 5 and 10 minutes after extubation
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Method of measurement
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Pulse oximetry
4
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Description
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Oxygen saturation percentage
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Timepoint
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Before extubation and 1, 3, 5 and 10 minutes after extubation
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Method of measurement
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Pulse oximetry
5
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Description
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Mean arterial pressure
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Timepoint
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Before extubation and 1, 3, 5 and 10 minutes after extubation
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Method of measurement
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Barometer
Secondary outcomes
1
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Description
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Duration of staying in recovery
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Timepoint
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Based on minutes from arrival to reaching the modified aldrete score of 9
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Method of measurement
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Information collection form
2
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Description
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Adverse airway response
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Timepoint
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During the time of staying in recovery
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Method of measurement
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Information collection form
3
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Description
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Hemodynamic complications
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Timepoint
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During the time of staying in recovery
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Method of measurement
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Information collection form
4
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Description
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Duration of extubation
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Timepoint
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Based on minutes from the time of discontinuing anesthetics to the time of extubation
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Method of measurement
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Information collection form
Intervention groups
1
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Description
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Intervention group 1: In this group, a syringe containing labetalol (0.1 mg / kg diluted with 0.9% saline to a volume of 5 ml) will be injected.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: In this group, a syringe containing labetalol (0.2 mg / kg, diluted with 0.9% saline to a volume of 5 ml) will be injected.
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Category
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Treatment - Drugs
3
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Description
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Control group: In this group Syringe containing 5 ml of 0.9% saline will be injected.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Unidentifiable individual data including hemodynamic indices and complications in all three groups can be shared.
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When the data will become available and for how long
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6 months after publication of paper
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To whom data/document is available
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Academic and medical researchers
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Under which criteria data/document could be used
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Use for research and treatment purposes
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From where data/document is obtainable
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Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir
Dr Hamidreza Shetabi
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What processes are involved for a request to access data/document
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If possible, it will be sent via email up to a maximum of 1 month after applying.
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Comments
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