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Investigating the preventive effect of two different doses of dexmedetomidine on the incidence of cough and respiratory complications during extubation compared to the control group.

Protocol summary

Study aim
General aim: to determine the preventive effect of two different doses of dexmedetomidine on the occurrence of cough and respiratory complications during tracheal tube removal compared to the control group
Design
A clinical trial with a control group, with parallel groups, three blind strains, randomized, phase 2 and 3 on 105 patients. Random allocation statistical software was used for randomization.
Settings and conduct
The present study is a three-blind randomized clinical trial that will be conducted at Ayatollah Kashani Medical Center. In this study, there are two intervention groups and one control group, and people are randomly assigned to these groups. The intervention method is described above. The study participants, the person who collects the data, and the data analyst are not aware of the study groups
Participants/Inclusion and exclusion criteria
Entry criteria: age between 18-65 years, ASA 1,2, need general anesthesia with tracheal intubation Exclusion criteria: patients with heart failure, respiratory failure, renal failure, hepatic failure, known allergy to the studied drugs, heart block, uncontrolled blood pressure, smokers and addiction to any type of addictive substance
Intervention groups
Group 1: 0.5 μg/kg dexmedetomidine bolus followed by 0.3 μg/kg infusion, ten minutes before tracheal tube removal. Group 2: 0.5 μg/kg dexmedetomidine bolus followed by 0.5 μg/kg infusion, ten minutes before tracheal tube removal. Group 3 (control): 10 minutes before leaving the tracheal tube, normal saline is injected with an equal volume of groups one and two as a bolus, and then with an equal volume of the other two groups as an infusion.
Main outcome variables
The frequency of coughing and the intensity of coughing during extubation, which is recorded from the time of full awakening to 5 minutes after extubation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090129001615N8
Registration date: 2023-05-13, 1402/02/23
Registration timing: prospective

Last update: 2023-05-13, 1402/02/23
Update count: 0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Azim Honarmand
Name of organization / entity
Alzahra hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
honarmand@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the preventive effect of two different doses of dexmedetomidine on the incidence of cough and respiratory complications during extubation compared to the control group.
Public title
Investigating the effective dose of dexmedetomidine in preventing cough during extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years ASA1,2 need general anesthesia with tracheal intubation
Exclusion criteria:
Patients with heart failure Patients with respiratory failure Patients with renal failure Patients with hepatic failure Previous known allergy to study drugs heart block Uncontrolled blood pressure smokers Addiction to any type of addictive substance
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software, patients are divided into three groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study participants, the person who collects the data, and the data analyst are not aware of the study groups
Placebo
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
Hezar jarib Ave., Isfahan university of medical sciencies
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.MUI.MED.REC.1402.047

Health conditions studied

1

Description of health condition studied
respiratory complications during extubation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Frequency of coughing during extubation
Timepoint
From the time of full awakening to 5 minutes after extubation
Method of measurement
Using direct observation, the occurrence or non-occurrence of cough is recorded

2

Description
severity of cough
Timepoint
From the time of full awakening to 5 minutes after extubation
Method of measurement
Minogue scale

Secondary outcomes

1

Description
Determination and comparison of systolic blood pressure in three groups
Timepoint
5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
Dial sphygmomanometer

2

Description
Determination and comparison of diastolic blood pressure in three groups
Timepoint
5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
Dial sphygmomanometer

3

Description
Determination and comparison of mean arterial pressure in three groups
Timepoint
5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
Dial sphygmomanometer

4

Description
Determination and comparison of heart rate in three groups
Timepoint
5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
pulse oximeter

5

Description
Determination and comparison of respiratory rate in three groups
Timepoint
5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
observation

6

Description
Determining and comparing the average dose of lidocaine and fentanyl used to control cough
Timepoint
From the time of full awakening to 5 minutes after extubation
Method of measurement
observation

7

Description
Determining and comparing the average dose of labetalol used in three groups
Timepoint
From the time of full awakening to 5 minutes after extubation
Method of measurement
observation

8

Description
Determining and comparing the average duration of surgery and anesthesia and stay in recovery in three groups
Timepoint
From the beginning of surgery to exit from recovery
Method of measurement
observation

9

Description
Determining and comparing the average dose of ondansetron consumed in three groups
Timepoint
From the time of full awakening to 5 minutes after extubation
Method of measurement
observation

10

Description
Determination and comparison of pain intensity in three groups
Timepoint
Every 15 minutes in recovery until leaving it
Method of measurement
Visual Analogue Scale

11

Description
Determining and comparing the frequency of nausea and vomiting in three groups
Timepoint
Every 15 minutes in recovery until leaving it
Method of measurement
observation

12

Description
Determining and comparing the average duration of extubation in three groups
Timepoint
At the time of extubation
Method of measurement
observation

13

Description
Determining and comparing the average level of consciousness in three groups
Timepoint
at 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery
Method of measurement
Using a 4-point scale, 0=sleepy and unresponsive 1=sleepy but can be woken up 2=sleepy but opens eyes with voice command 3=fully alert

Intervention groups

1

Description
Intervention group 1: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.3 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed.
Category
Treatment - Drugs

2

Description
Intervention group2: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.5 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed.
Category
Treatment - Drugs

3

Description
Control group: 10 minutes before remove the tracheal tube, normal saline is injected with an equal volume of groups 1 & 2 as a bolus and then with an equal volume of the other two groups as an infusion. It is necessary to explain that if a patient in this group has a continuous cough, tachycardia with heart rate above 100 times per minute, blood pressure increase to systolic pressure above 140 and diastolic pressure above 90 mm Hg, lidocaine with a dose of 1.5 mg/kg is used for control, if there is no response to lidocaine fentanyl It is injected at a dose of 2 μg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Azim Honarmand
Street address
Ayatollah Kashani Street, Ayatollah Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
Email
honarmand@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Azim Honarmand
Street address
Shohada Soffeh Street., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
Honarmand@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Soffeh Street., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
Honarmand@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Soffeh Street., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
Honarmand@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Soffeh Street., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
Honarmand@med.mui.ac.ir

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
Undecided - It is not yet known if there will be 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
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