Comparison of the effect of dexmedetomidine and lidocaine on cough caused by fentanyl injection in patients undergoing elective surgery in Shahid Mohammadi Hospital, Bandar Abbas
Design
Prospective, double-blind, single-group clinical trial, data are analyzed by SPSS software using Chi-square and t-test.
Settings and conduct
This study will be performed as a prospective clinical trial on patients who will refer to Shahid Mohammadi Hospital for elective surgery in 1400. Patients are included in the study according to the inclusion criteria and written consent is obtained from all of them to participate in the study. Then all the desired variables including age, sex, height and weight of patients will be collected. Patients are then randomly divided into three groups according to a random allocation table.
To blind patients, the first group will receive the equivalent volume of lidocaine from normal saline solution 90 seconds before prodrug and the second and third group patients will receive 10 ml of isotonic saline 10 minutes before prodrug administration.
After administration of these drugs, all patients received 2 μg / kg fentanyl from a 50 μg / ml vial (Caspian Drug Company / Rasht / Iran) intravenously for 5 seconds and 2 minutes after fentanyl injection, patients were exposed to (Yes / No) and we will examine the severity of cough (2-1 mild / 5-3 moderate /> severe 5).
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with ASA I and II undergoing elective surgery in 1400.
Intervention groups
Comparison of the efficacy of lidocaine and dexmedetomidine
Main outcome variables
Cough intensity; Cough incidence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052848N1
Registration date:2021-11-17, 1400/08/26
Registration timing:prospective
Last update:2021-11-17, 1400/08/26
Update count:0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Fatemeh Taherzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5343 3591
Email address
zhrkrdn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dexmedetomidine and lidocaine on fentanyl induced cough in patients undergoing elective surgery
Public title
Comparison of the effect of dexmedetomidine and lidocaine on fentanyl induced cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidates for elective surgery taking fentanyl.
Patients aged 18-65 years
Informed consent
Exclusion criteria:
Patients taking fentanyl are not candidates for elective surgery.
Patients receiving corticosteroids
A person with a history of asthma and respiratory diseases in the previous 4 weeks
A person with a history of allergies to fentanyl or dexmedetomidine
Patients in need of emergency surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
171
Randomization (investigator's opinion)
Randomized
Randomization description
Epidemiologist download the random allocation software from http://random-allocation-software-inform.com,which this random sequence generation software in addition to randomization is able to generate random sequences in different ways.Simple randomization was done in each group through random allocation software (version 1.0.0 ) and entered the number of groups,sample size and group name into main windows icon,then a sequence of 171 cases(equal to sample size) was created using the Rnd function that the patients randomly and based on this random sequence table,enter to one of groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind patients, the first group will receive the equivalent volume of lidocaine from normal saline solution 90 seconds before the prodrug and the second and third group patients will receive 10 ml of isotonic salibene 10 minutes before the prodrug administration. All this information will be provided by an anesthesia assistant who does not know the grouping and how to inject the drugs. Because the patients are also unaware of the groups, the study is double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Medical Sciences - School of Medicine
Street address
Imam Hossein Boulevard, Tohid Town
City
Bandarabbas
Province
Hormozgan
Postal code
7915865883
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.HUMS.REC.1400.276
Health conditions studied
1
Description of health condition studied
fentanyl indeuced cough
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
incidence of cough
Timepoint
Evaluation of cough in patients candidates for elective surgery, two minutes after fentanyl injection
Method of measurement
Cough incidence questionnaire
2
Description
Intensity of cough
Timepoint
Evaluation of cough severity in patients candidates for elective surgery, two minutes after fentanyl injection
Method of measurement
Cough Intensity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Lidocaine: 1.5 mg / kg intravenously for 90 seconds before fentanyl injection
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2: Dexmedetomidine: 0.5 μg / kg solution of 10 cc of isotonic saline 10 minutes before anesthesia, by infusion
Category
Treatment - Drugs
3
Description
Control group: normal saline at a dose of 1.5 mg / kg for 90 seconds before fentanyl injection as infusion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital, Bandar Abbas
Full name of responsible person
Fatemeh Taherzadeh
Street address
North Mission, Sadeghieh Square
City
Bandar Abbas
Province
Hormozgan
Postal code
7915865883
Phone
+98 71 5343 3591
Email
ZHRKRDN@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hashem Jarineshin
Street address
North Mission, Sadeghieh Square
City
Bandar Abbas
Province
Hormozgan
Postal code
7915865883
Phone
+98 71 5343 3591
Email
ZHRKRDN@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
North Mission, Sadeghieh Square
City
Bandar Abbas
Province
Hormozgan
Postal code
7915865883
Phone
+98 76 3334 5009
Email
drfatemehtaherzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
North Mission
City
Bandar Abbas
Province
Hormozgan
Postal code
7915865883
Phone
+98 76 3334 5009
Email
hjarineshin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Taherzadeh
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
North Mission
City
Bandar Abbas
Province
Hormozgan
Postal code
7915865883
Phone
+98 76 3334 5009
Email
drfatemehtaherzadeh@gmail.com
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
No - There is not 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