History
# Registration date Revision Id
2 2021-12-11, 1400/09/20 211352
1 2020-11-30, 1399/09/10 160889
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  • Protocol summary

    Determining and comparing the effect of 0.2 and 0.4 mg/kg of intravenous labetalol on the cardiovascular response to tracheal extubation
    Determining and comparing the effect of 0.1 and 0.2 mg/kg of intravenous labetalol on the cardiovascular response to tracheal extubation
    تعیین و مقایسه‌ی تاثیر دوزهای 0.2 و 0.4 میلیگرم بر کیلوگرم لابتالول وریدی بر پاسخ قلبی‌عروقی به خروج لوله تراشه
    تعیین و مقایسه‌ی تاثیر دوزهای 0.1 و 0.2 میلیگرم بر کیلوگرم لابتالول وریدی بر پاسخ قلبی‌عروقی به خروج لوله تراشه
    این مطالعه یک کارآزمایی بالینی تصادفی شده ی دوسوکور و دارای گروه کنترل میباشد که بر روی 72 بیمار کاندید جراحی الکتیو انجام می شود. برای تصادفی سازی از روش بلوک جایگشتی استفاده میشود.
    این مطالعه یک کارآزمایی بالینی تصادفی شده ی دوسوکور و دارای گروه کنترل میباشد که بر روی 72 بیمار کاندید جراحی الکتیو انجام می شود. برای تصادفی سازی از روش بلوک جای گشتی استفاده میشود.
    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.
    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.
    محل انجام مطالعه: بیمارستان الزهرا اصفهان؛ نوع کورسازی: دوسوکور؛ نحوه ی کورسازی: بیمار و مشاهده‌گری که اطلاعات را جمع‌آوری میکند از گروه‌بندی دارویی بی‌ اطلاع خواهند بود؛ روش کار: بر روی 72 نفر (24 نفر در هر گروه) از بیماران کاندید جراحی الکتیو در بیمارستان الزهرا دوزهای 0.2 ، 0.4 میلیگرم بر کیلوگرم لابتالول وریدی و نرمال‌سالین مورد استفاده قرار خواهد گرفت.
    محل انجام مطالعه: بیمارستان الزهرا اصفهان؛ نوع کورسازی: دوسوکور؛ نحوه ی کورسازی: بیمار و مشاهده‌گری که اطلاعات را جمع‌آوری میکند از گروه‌بندی دارویی بی‌ اطلاع خواهند بود؛ روش کار: بر روی 72 نفر (24 نفر در هر گروه) از بیماران کاندید جراحی الکتیو در بیمارستان الزهرا دوزهای 0.1 و 0.2 میلیگرم بر کیلوگرم لابتالول وریدی و نرمال‌سالین مورد استفاده قرار خواهد گرفت.
    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%
    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%
    گروه مداخله 1: لابتالول (0.2 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) گروه مداخله 2: لابتالول (0.4 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) گروه کنترل: 5ml سالین 0.9%
    گروه مداخله 1: لابتالول (0.1 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) گروه مداخله 2: لابتالول (0.2 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) گروه کنترل: 5ml سالین 0.9%
  • General information

    empty
    Evaluation of the effect of lower doses of labetalol on hematodynamic response to endotracheal tube extubation
    empty
    بررسی تاثیردوزهای کمترلابتالول بر پاسخ همودینامیک به خروج لوله تراشه
  • Intervention groups

    #1
    Intervention group 1: In this group Syringe containing Labetalol (0.2 mg/kg diluted with 0.9% saline to 5 ml) will be injected.
    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.
    گروه مداخله اول: در این گروه سرنگ حاوی لابتالول (0.2 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) تزریق خواهد شد.
    گروه مداخله اول: در این گروه سرنگ حاوی لابتالول (0.1 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) تزریق خواهد شد.
    #2
    Intervention group 2: In this group Syringe containing Labetalol (0.4 mg/kg diluted with 0.9% saline to 5 ml) will be injected.
    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.
    گروه مداخله دوم: در این گروه سرنگ حاوی لابتالول (0.4 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) تزریق خواهد شد.
    گروه مداخله دوم: در این گروه سرنگ حاوی لابتالول (0.2 میلیگرم بر کیلوگرم رقیق شده با سالین 0.9% تا حجم 5ml) تزریق خواهد شد.
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidraza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidraza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Assistant Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamidreza Shetabi
    Full name of responsible person - Persian: حمیدرضا شتابی
    Position - English: Associate proffesor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Al-Zahra Hospital; Sofe bolevard
    Street address - Persian: بلوار صفه؛ بیمارستان الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Mobile: +98 913 115 3104
    Fax:
    Email: hamidshetabi@med.mui.ac.ir
    Web page address:

Protocol summary

Study aim
Determining and comparing the effect of 0.1 and 0.2 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 0.1, 0.2 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 (0.1 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%
Main outcome variables
Systolic blood pressure؛ Diastolic blood pressure؛ Median arterial blood pressure؛ Heart rate؛ O2 saturation

General information

Reason for update
Evaluation of the effect of lower doses of labetalol on hematodynamic response to endotracheal tube extubation
Acronym
IRCT registration information
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
Registration date
2020-11-30, 1399/09/10
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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, a syringe containing labetalol (0.1 mg / kg diluted with 0.9% saline to a volume of 5 ml) will be injected.
Category
Treatment - Drugs

2

Description
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.
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
Associate 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
Associate proffesor
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.
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