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the effect of pheniramin maleat on fentanyl induced cough during anesthetic induction in opium addicts

Protocol summary

Study aim
To prevent fentanyl-induced cough and its complications during induction of anesthesia ,using chlorpheniramine in opium addicts
Design
Randomized double-blind prospective clinical trial
Settings and conduct
86 patients class1-2 ASA undergoing elective surgury after obtaining informed contest, will be separated into two groups ( control and intervention) by using randomizing software. patients will be monitored including pulse oxymetry,non invasive blood pressure, and ECG and vital signs would be recorded:(pulse rate, systolic and diastolic blood pressure , temrature, respiratory rate).ringer serum will be infused 3cc/kg in all patients.In control group 2cc N/s 0.9 and in intervention group 20 mg(2cc) pheniramin maleat will be injected iv.After 90 second 2mic/kg fentanyl will be injected iv during3 seconds.90 second after fentanyl injection, severity of cough will be devided into 3 groups(mild:1-2, moderate:3-4, severe>5 ) and vital sign will be recorded . Induction of anesthesia will be finished by injecting propofol10mg/kg, atracorium 0.5 mg/ kg intravenously.
Participants/Inclusion and exclusion criteria
inclusion criteria:addict to opioids, ages between18-65 years, undergoing elective surgeory Exclusion criteria:history of chronic lung disease, asthma, chronic cough, flu, history of using anti-cough drugs,incresed intra cranial, intra abdominal and intra occular pressure,
Intervention groups
control group: injection of 2cc nacl 0.9, 90 seconds before iv injection of 2 Mic /kg fentanyl inrevention group: Injection of 20 mg (2cc) pheniramine maleat 90 seconds before iv injection of 2 Mic/kg fentanyl
Main outcome variables
fentanyl induced cough and its complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191204045603N1
Registration date: 2020-03-15, 1398/12/25
Registration timing: retrospective

Last update: 2020-03-15, 1398/12/25
Update count: 0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
zahra salehinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 5890
Email address
zumyad83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of pheniramin maleat on fentanyl induced cough during anesthetic induction in opium addicts
Public title
the effect of chlorpheniramin on fentanyl induced cough
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
addiction to opium 18-65 years old patients undergoing elective surgury class1-2 ASA
Exclusion criteria:
history of chronic lung disase recent respiratory infection,pharangitis using drugs that inhibit cough like captoprill increased intra cranial, abdominal,occular pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization in individuals with statistic software
Blinding (investigator's opinion)
Double blinded
Blinding description
It is told to the patient that a drug is going to be injected to him/her for preventing cough during anesthesia, and he does not know if placebo or pheniramin maleat would be injected before fentanyl administration. the anesthesiologist who inject the drug and record informations, dose not know if placebo or chlorpheniramin would be injected before fentanyl administration.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ocfMashhad university of medical siciences
Street address
no.45,in front of Daneshgah 18, Daneshgah blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۸۸۱۳۹۴۴
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
960516

Health conditions studied

1

Description of health condition studied
fentanyl induced cough
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
fentanyl induced cough
Timepoint
90 seconds after injection of fentanyl
Method of measurement
counting number of cough

Secondary outcomes

empty

Intervention groups

1

Description
injection of 20 mg pheniramin maleat iv, 90 seconds before iv injection of fentanyl 2mic/kg.
Category
Treatment - Drugs

2

Description
Control group: injection of 2cc N/S 0.9 , 90 seconds before fentanyl inejection 2mic/kg
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Darabi
Street address
imam reza square, Ebne-sina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
emamreza@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hossein Bahraini
Street address
Daneshgah ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
10
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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Salehinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 37, Malek Ashtar 9, Ershaad Blvd. , Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9135877393
Phone
+98 51 3761 5890
Email
salehinezhadz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Salehinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 37, Malek Ashtar 9, Ershaad Blvd. , Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9135877393
Phone
+98 51 3761 5890
Email
salehinezhadz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Salehinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 37, Malek Ashtar 9, Ershaad Blvd. , Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9135877393
Phone
+98 51 3761 5890
Email
salehinezhadz@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Zahra Salehinezhad salehinezhadz951@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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