Comparison of safety and efficacy of two doses of Dexmedetomidine in reducing the incidence of cough after endotracheal tube removal in a patient undergoing elective surgery
Determining and comparing the safety and efficacy of two different doses of dexmedetomidine in reducing the incidence of cough after endotracheal tube removal in a patient undergoing elective surgery
Design
Clinical trial with control group, with parallel, non-blind, non-random groups
Settings and conduct
Study place: Al-Zahra Hospital, Isfahan. Type of blinding: Not blinded Methods: It will be used on three groups of 60 candidates for elective surgery in Al-Zahra Hospital. In doses of one microgram and a half micrograms per kilogram and the control group with 100 ml of normal saline will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Candidates for elective surgery
Age range 60-18 years and with ASA was class 1 and 2.
Patient consent to participate in the study
Criteria for not entering: History of allergy to alpha adrenergic drugs
Liver patients
History of bradycardia Block av grade 2 or 3
Vascular problems
low blood pressure، Hypovolemia، Vasodilator use، Addicted people، smoker Patients with airway infection or history of airway surgery , Asthma sufferers، Those at risk for increased intracranial pressure and intraocular pressure، Use of antihypertensive drugs or digoxin and GABA pentin.
Intervention groups
Intervention 1: Dexmedetomidine 1mcg / kg diluted in 100 ml of normal saline. Second intervention: Dexmedetomidine 0.5 mce / kg diluted in 100 ml of normal saline. Control group: 100 ml of normal saline.
Comparison of safety and efficacy of two doses of Dexmedetomidine in reducing the incidence of cough after endotracheal tube removal in a patient undergoing elective surgery
Public title
The effect of dexmedetomidine on reducing the incidence of cough after extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for elective surgery
Age range is 18-60 years and with ASA class 1 and 2.
Patient consent to participate in the study
Exclusion criteria:
History of allergy to Alpha adrenergic drugs
Liver patients
Patients with a history of Bradycardia
Vascular problems
Hypotension
Vasodilator use
Hypovolemia
People who are at risk for increased intracranial pressure or intraocular pressure
Addicted people or Smokers
People with asthma
Patients with a history of airway infection or history of airway surgery.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
540
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Hezarjarib Blvd, Isfahan University of Medical Science
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-17, 1399/10/28
Ethics committee reference number
IR.MUI.MED.REC.1399.954
Health conditions studied
1
Description of health condition studied
Tracheal Extubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic bBlood 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
6
Description
Cough
Timepoint
1, 3, 5 and 10 minutes after the end of the extubation
Method of measurement
View
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 anesthetic to the time of extubation
Method of measurement
Information collection form
Intervention groups
1
Description
Intervention group 1: In this group, the syringe containing dexmedetomidine (from Behestan Daroo company) is diluted to 1mcg / kg in 100 ml of normal saline and infused into the patient within ten minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, the syringe containing dexmedetomidine (from Behestan Daru company) is diluted at the rate of 0.5mcg / kg in 100 ml of normal saline and is infused into the patient within ten minutes.
Category
Treatment - Drugs
3
Description
Control group: In this group, the syringe containing 100 ml of normal saline is infused into the patient within 10 minutes.
Category
Placebo
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 boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 8138
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 science. Hezarjirib St.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Email
Research@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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AL-zahra hospital; Sofe boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+980313622020
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
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AL-zahra hospital; Sofe boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+980313622020
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 boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+980313622020
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 of participants including hemodynamic indicators and complications can be shared in all three groups.
When the data will become available and for how long
6 month after publication of paper
To whom data/document is available
Academic and medical researcher
Under which criteria data/document could be used
Use for research and treatment purpose
From where data/document is obtainable
Email of person in charge of public accountability ,Dr Hamidreza Shetabi:
hamidshetabi@med.mui.ac.ir
What processes are involved for a request to access data/document
After the request, it will be sent by email, if possible, within a maximum of one month.