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The effect of duration of injection time on the incidence and severity of fentanyl-induced cough (FIC)

Protocol summary

Study aim
The effect of duration of injection time on the incidence and severity of fentanyl-induced cough (FIC)
Design
This clinical trial will consist of three groups, double-blind, randomized, and parallel. Samples will be determined using Block Randomization method, Allocation Random Software and based on injection rate of 150 pcs. The numbers x≤50 will fall into the first group, 50˂x≤100 in the second group, and 100˂x≤150 into the third group. Patients will receive fentanyl over the course of 2–5 seconds in the first group, 15 seconds in the second group, and 30 seconds in the third group.
Settings and conduct
This double blind clinical trial study will be conducted on 150 patients with ASA1 candidates for elective surgery in Shahid Mohammadi hospital in Bandar Abbas. Patients will receive fentanyl over the course of 2–5 seconds in the first group, 15 seconds in the second group, and 30 seconds in the third group. Patients will not be aware of the duration of fentanyl injection. Information will be recorded in a special form by an experienced anesthesiologist who will be unaware of the study process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient age between 18-50 years, physical status (ASA I) and candidate for elective surgery. Exclusion criteria: Patients with a history of asthma, chronic cough, respiratory infection in the past 4 weeks, Angiotensin converting enzyme inhibitor drugs, smoking, drug use, bronchodilator or steroid administration, Abnormal and extra sounds in the heart and lungs
Intervention groups
Intravenous injection of fentanyl will be given in three groups for 2, 15 and 30 seconds, respectively.The severity and incidence of cough will be recorded in a special form within 2 minutes after intravenous injection of fentanyl.
Main outcome variables
Incidence and severity of cough during anesthesia induction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200108046052N2
Registration date: 2020-02-28, 1398/12/09
Registration timing: registered_while_recruiting

Last update: 2020-02-28, 1398/12/09
Update count: 0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
Motahareh Khojastehrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3380 0885
Email address
motahareh.khojastehrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-03-21, 1399/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of duration of injection time on the incidence and severity of fentanyl-induced cough (FIC)
Public title
The effect of fentanyl on cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 18-50 years Physical Condition (ASA I) Candidate for elective surgery
Exclusion criteria:
Patients with a history of asthma Chronic cough Respiratory infection during the last 4 weeks Angiotensin converting enzyme inhibitor drugs Smoking Opioids users Use of bronchodilators or steroids Abnormal and excessive sounds in the heart and lungs
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number generating software, 150 random numbers were obtained. The numbers x≤50 fall into the first group, 50˂x≤100 in the second group, and 100˂x≤150 into the third group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the duration of fentanyl injection. The information is recorded by an experienced anesthesiologist who was unaware of the study process and recorded in a special form.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Bandar Abbas University of Medical Sciences
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.HUMS.REC.1394.184

Health conditions studied

1

Description of health condition studied
Cough induced by injection of fentanyl in induction of anesthesia
ICD-10 code
A37.9
ICD-10 code description
Whooping cough, unspecified species

Primary outcomes

1

Description
Severity and incidence of fentanyl injection cough
Timepoint
Within 2 minutes after intravenous injection of fentanyl
Method of measurement
Classification form Incidence and severity of cough

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Fentanyl will be injected intravenously during 2 seconds. While receiving oxygen (6 l/min), all patients will receive Fentanyl (Feniject 0.5 mg/10 ml, Aburaihan Co. in Iran) by an anesthesiologist at the dose of 2 μg/kg.
Category
Treatment - Drugs

2

Description
Intervention group 2: Fentanyl will be injected intravenously during 15 seconds. While receiving oxygen (6 l/min), all patients will receive Fentanyl (Feniject 0.5 mg/10 ml, Aburaihan Co. in Iran) by an anesthesiologist at the dose of 2 μg/kg.
Category
Treatment - Drugs

3

Description
Intervention group 3: Fentanyl will be injected intravenously during 30 seconds. While receiving oxygen (6 l/min), all patients will receive Fentanyl (Feniject 0.5 mg/10 ml, Aburaihan Co. in Iran) by an anesthesiologist at the dose of 2 μg/kg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi hospital
Full name of responsible person
Hashem Jarineshin
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7002
Email
motahareh.khojastehrad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7003
Email
motahareh.khojastehrad@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7001
Email
hjarineshin@yahoo.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
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
0987633347001
Email
hjarineshin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Motahareh KHojasteh Rad
Position
Anesthesiologist
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Shahid Mohammadi hospital, Republic Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7002
Email
motahareh.khojastehrad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only the results section can be shared.
When the data will become available and for how long
Start access period 3 months after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Announced as a reference.
From where data/document is obtainable
motahareh.khojastehrad@gmail.com
What processes are involved for a request to access data/document
Send request by email
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