Protocol summary
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Study aim
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To determine the effect of lidocaine and Huffing maneuver in preventing reflective cough after rapid fentanil injection
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Design
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Prospective randomized controlled clinical trial
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Settings and conduct
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400 Patients in the Namazi Hospital are randomly divided into four groups of each 100.
100 people are considered as control group.
First intervention group: Patients receive 2 mg / kg lidocaine before injection of fentanil.
Second intervention group: Huffing maneuver is performed for patients before injection of fentanil.
Third intervention group: patients received 2 mg / kg lidocaine with Huffing maneuver .
Fourth intervention group:Combined protocol (2 mg / kg lidocaine is injected one minute before fentanil injection and after 55 seconds, huffing maneuver is performed after a deep breath less than 5 seconds, and followed by fentanil 2.5 µg/kg and patients are checked every two minutes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 16 - 65 years old; elective surgery.
Exclusion criteria: Asthma; Chronic cough; upper respiratory tract infection two weeks before surgery; smoking; steroid therapy;using bronchodilatorand ACE inhibitor.
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Intervention groups
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First intervention group: Patients receive 2 mg / kg lidocaine before injection of fentanil.
Second intervention group: Huffing maneuver is performed before injection of fentanil.
Third intervention group: Injection of 2 mg / kg lidocaine with Huffing maneuver on patients.
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Main outcome variables
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Existence or absence of cough reflex and also the severity of coughing are evaluated.1-2 coughs grade one, 3-4 coughs grade 2 and 5 and more than 5 coughs considered as grade 3.
General information
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Reason for update
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Due to the inconsistency recorded in the date of the Ethical approval code and Forgetting to correct the date, please correct the date.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N74
Registration date:
2018-03-09, 1396/12/18
Registration timing:
prospective
Last update:
2021-01-18, 1399/10/29
Update count:
1
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Registration date
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2018-03-09, 1396/12/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-15, 1396/12/24
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Expected recruitment end date
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2018-09-15, 1397/06/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of Lidocaine, Huffing Maneuver and combination of both in prevention fentanil induced cough before induction of anesthesia
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Public title
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The relation between Lidocaine and Huffing Maneuver in prevention of cough after fentanil injection
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 16 - 65 years old, elective surgery
Exclusion criteria:
Asthma; Chronic cough, upper respiratory tract infection two weeks before surgery; smoking; steroid therapy;using bronchodilator and ACE inhibitor.
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Age
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From 16 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
400
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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only observer after intervention is blinded to the study
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-03-03, 1393/12/12
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Ethics committee reference number
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IR.SUMS.MED.RED.1394.61
Health conditions studied
1
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Description of health condition studied
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The relation between Lidocaine and Huffing Maneuver in prevention of cough after fentanil injection
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Cough reflect
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Timepoint
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2 minutes after fentanil injection
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Method of measurement
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Observation
Intervention groups
1
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Description
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Control group:
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Category
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N/A
2
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Description
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Intervention group:
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Category
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Prevention
3
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Description
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Intervention group:
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Category
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Prevention
4
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Description
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Intervention group:
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is against the policies of our center.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable