Evaluation of the effect of anesthesia induction with three medicinal compounds midazolam-nessodal, propofol 2 and etomidate-propofol compared to thiopental alone on changes in heart rate and blood pressure during laryngeal mask application in eye surgery
Comparative study of the effect of induction of anesthesia with the three medicinal compounds midazolam-nesdonaم, ketamine-propofol, and ethmidite-ketamine on hemodynamics and laryngeal mask application conditions in cataract surgery.
Design
A clinical trial without a parallel control group, single blind, randomized
Settings and conduct
In this randomized single-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 three 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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
We have three intervention groups. The first group consisted of midazolam - nesodal , the second group propofol and the third group the combination of prophylactic - propofol given.
Main outcome variables
Heart rate; blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N27
Registration date:2020-01-07, 1398/10/17
Registration timing:prospective
Last update:2020-01-07, 1398/10/17
Update count:1
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-09-15, 1399/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of anesthesia induction with three medicinal compounds midazolam-nessodal, propofol 2 and etomidate-propofol compared to thiopental alone on changes in heart rate and blood pressure during laryngeal mask application in eye surgery
Public title
The effect of induction of anesthesia with three drug compositions compared to thiopental alone on changes in heart rate and blood pressure during laryngeal mask application in eye surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
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.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into three parallel groups using the Random Allocation Random Block software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding is that the drug groups are placed in numbered syringes by the planter, giving each group its own number, and the drugs are covered with a black sheet that has the same appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.MUI.MED.REC.1398.448
Health conditions studied
1
Description of health condition studied
Adverse effects of general anesthetics
ICD-10 code
T41.205
ICD-10 code description
Adverse effect of unspecified general anesthetics
Primary outcomes
1
Description
Heart rate
Timepoint
Before tube placement and 1, 3 and 5 minutes after LMA application
Method of measurement
Oximeter pulse
2
Description
blood pressure
Timepoint
Before tube placement and 1, 3 and 5 minutes after LMA application
Method of measurement
Barometer
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: The first group is given a combination of midazolam (0.04 mg / kg) - neodonal (2.5 mg / kg).
Category
Treatment - Drugs
2
Description
Second Intervention Group: The second group is given propofol (5 mg / kg).
Category
Treatment - Drugs
3
Description
Third intervention group: The third group is given the combination of etomidate (0.1 mg / kg) - propofol (1 mg / kg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Kamran Montazeri
Street address
Qods Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
montazeri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Qods square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
montazeri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Qods square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
montazeri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Qods square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
montazeri@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Feiz hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.