Protocol summary
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Study aim
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Evaluation of the effect of anesthesia induction with three medicinal compounds midazolam-nesdonal, propofol, and etomidate-propofol compared to thiopental alone on changes in heart rate and blood pressure during laryngeal mask application in eye surgery
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Design
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A clinical trial without a parallel control group, double blind, randomized
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Settings and conduct
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In this randomized double-blind clinical trial, 128 patients who are candidates for general anesthesia cataract surgery are selected according to the study conditions, then the patients are randomly divided into four parallel groups. Then hemodynamic data including systolic and diastolic blood pressure, pulse rate, arterial oxygen saturation were recorded before tube placement and 1, 3 and 5 minutes after LMA administration. Duration of surgery and anesthesia is the duration of recovery in each group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients who have indications for general anesthesia surgery and LMA surgery; Age over 18 years; ASA score or American Society of Anesthesiologists score 1 or 2; Consent to participate in the study; Exclusion criteria: If you have an underlying or systemic illness such as kidney failure, or uncontrolled heart failure, etc.
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Intervention groups
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We have four intervention groups. The first group was given midazolam-nesdonal combination, the second group propofol, the third group propofol and the fourth group thiopental.
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Main outcome variables
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Heart rate; Blood pressure
General information
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Reason for update
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The reason for the change is correction of writing and grammar of scientific and public titles sections.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171030037093N27
Registration date:
2020-01-07, 1398/10/17
Registration timing:
prospective
Last update:
2020-02-14, 1398/11/25
Update count:
1
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Registration date
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2020-01-07, 1398/10/17
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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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2020-02-16, 1398/11/27
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Expected recruitment end date
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2020-09-15, 1399/06/25
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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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Evaluation of the effect of anesthesia induction with three medicinal compounds midazolam-nesdonal, propofol, and etomidate-propofol compared to thiopental alone on changes in heart rate and blood pressure during laryngeal mask application in eye surgery
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Public title
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Comparison of efficacy of 4 anesthesia methods on changes in heart rate and blood pressure during laryngeal mask application
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who have indications for general anesthesia surgery and LMA surgery
Age over 18 years
ASA score or American Society of Anesthesiologists score 1 or 2
Consent to participate in the study
Exclusion criteria:
If you have an underlying or systemic illness such as kidney failure, or uncontrolled heart failure, etc.
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly divided into four parallel groups by blocking method using the Random Allocation software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The method of blinding is that the drug groups are placed in numbered syringes by the researcher, giving each group its own number, and the drugs are covered by a black sheet having the same appearance.
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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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2019-11-27, 1398/09/06
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Ethics committee reference number
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IR.MUI.MED.REC.1398.448
Health conditions studied
1
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Description of health condition studied
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Adverse effect of general anesthetics
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ICD-10 code
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T41.205
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ICD-10 code description
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Adverse effect of unspecified general anesthetics
Primary outcomes
1
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Description
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Heart rate
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Timepoint
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Before intubation and 1, 3 and 5 minutes after LMA application
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Method of measurement
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Pulse oximetry
2
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Description
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Blood pressure
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Timepoint
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Before intubation and 1, 3 and 5 minutes after LMA application
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Method of measurement
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Barometer
Intervention groups
1
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Description
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First Intervention group: The first group is given a combination of midazolam (0.04 mg / kg) - nesdonal (2.5 mg / kg).
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Category
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Treatment - Drugs
2
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Description
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Second Intervention Group: The second group is given propofol (5 mg / kg).
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Category
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Treatment - Drugs
3
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Description
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Third intervention group: The third group is given the combination of etomidate (0.1 mg / kg) - propofol (1 mg / kg).
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Category
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Treatment - Drugs
4
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Description
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Control group: The control group is given thiopental (2.5 mg / kg).
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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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Information about the main outcome can be shared.
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When the data will become available and for how long
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Start the access period 4 months after publishing the results
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To whom data/document is available
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Researchers working in academia
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Under which criteria data/document could be used
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Use data to complete clinical trial studies
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From where data/document is obtainable
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Feiz hospital
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What processes are involved for a request to access data/document
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After the investigation of researcher request and presentation of required documents will be accessible.
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Comments
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