Protocol summary
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Study aim
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The effect of intravenous dexamethasone and lidocaine on reduction of respiratory and hemodynamics complications after general anesthesia in children undergoing cleft palate surgery.
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Design
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This study is a randomized double-blind, clinical trial with parallel groups.
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Settings and conduct
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This study will be carried out among patients undergoing cleft palate surgery at Imam Hossein Hospital in Isfahan, Iran, in 2018 .The drugs are in equal volumes and are encrypted in the same syringes. In addition the syringes will be coded. These jobs will be do to keep blinding. Patients, researcher and nurse-recorder do not know which group the patients are allocated to.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : candidates of cleft palate repair surgery with age range of 6 months old to 2 years old and patients with class I and II in American society of anesthesiologists (ASA) classification.
Exclusion criteria: prolonged surgical time more than 3 hours, post -operative bleeding and post-surgical complication
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Intervention groups
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The first group received intravenous dexamethasone (0.2 mg / kg), the second group received intravenous lidocaine (1 mg / kg) and the third group received placebo. The drugs were in equal volumes and they were prescribed before induction of anesthesia.
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Main outcome variables
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Mean arterial blood pressure; Heart rate; Severity of pain; Laryngospasm; Bronchospasm; Cough; Vomiting
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160301026866N8
Registration date:
2018-09-17, 1397/06/26
Registration timing:
prospective
Last update:
2019-01-07, 1397/10/17
Update count:
1
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Registration date
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2018-09-17, 1397/06/26
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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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2018-09-20, 1397/06/29
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Expected recruitment end date
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2019-01-20, 1397/10/30
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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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A comparative study on the effect of intravenous dexamethasone and intravenous lidocaine on reduction of hemodynamic and respiratory complications in children undergoing cleft palate surgery
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Public title
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Intravenous Dexamethasone and intravenous lidocaine in children undergoing cleft palate surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Six months to two years children
with ASA class I and II
without underlying illness
candidate for Cleft palate surgery
Exclusion criteria:
The presence of symptoms of upper respiratory tract infection
Coagulation disorder
Systemic diseases
other hereditary abnormalities
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Age
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From 6 months old to 2 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
115
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization with using Permuted block randomization, For this purpose, use 6-unit blocks. We start randomly from the number 4480 in the random number table And up to 7045, we will code a total of 18 blocks of 6 by the table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients, researcher and nurse-recorder do not know which group the patients are allocated to. Medications are prepared in similar syringes and in equal volumes.
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Placebo
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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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2015-08-11, 1394/05/20
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Ethics committee reference number
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Ir.Mui.Rec.1394.3.873
Health conditions studied
1
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Description of health condition studied
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Respiratory and hemodynamic complications in the cleft palate
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ICD-10 code
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Q35; Q36;
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ICD-10 code description
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Cleft palate; Cleft lip; Cleft palate with cleft lip
Primary outcomes
1
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Description
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Mean arterial blood pressure
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Timepoint
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Every 15 minutes during surgery and every 15 minutes in recovery room
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Method of measurement
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Anesthetic monitoring device
2
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Description
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Heart rate
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Timepoint
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Every 15 minutes during surgery and every 15 minutes in recovery room
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Method of measurement
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Anesthetic monitoring device
3
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Description
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Respiratory complications(Larangospasm, bronchospasm, coughing)
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Timepoint
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in the recovery room
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Method of measurement
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Recording the complications
4
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Description
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Intensity of pain
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Timepoint
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Every 15 minutes in recovery room
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group 1: Before induction of anesthesia, a recovery nurse will be administered to the first group of intravenous dexamethasone (0.2 mg / kg).
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Before induction of anesthesia, a recovery nurse will be administered to the second group of intravenous lidocaine (1mg / kg).
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo is given in equal volume.
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Category
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Treatment - Drugs
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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is shared
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When the data will become available and for how long
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6 months after printing results
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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For scientific research
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From where data/document is obtainable
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Amir Shafa
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What processes are involved for a request to access data/document
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Requested by email
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Comments
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