Comparative evaluation of the efficacy of three different doses of atracurium on Laryngeal Mask Airway insertion conditions in patients undergoing phacoemulsification surgery
Determination of the effectiveness of three different doses of atracurium on the conditions of laryngeal mask airway insertion in patients undergoing cataract surgery by phacoemulsification "
Design
Double-blind, randomized clinical trial using random computer numbers with parallel groups designed for 120 patients
Settings and conduct
Using three doses of atracurium in three groups of patients and comparing their effect on facilitating the use of the laryngeal mask (LMA)in cataract surgery by phacoemulsification in Faiz Hospital in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 30-80 years undergoing surgery by phacoemulsification with general anesthesia.
Non-inclusion criteria: Poor mouth opening Pharyngeal pathology Laryngeal pathology Pulmonary diseases Risk of aspiration (full stomach, gastroesophageal reflux disease, pregnancy) History of allergy to any anesthetic drugs High airway resistance
Intervention groups
The first group received atracurium 0.2mg / kg
The second group received atracurium 0.4 mg / kg
The third group received atracurium 0.6 mg / kg
Main outcome variables
Time of insertion of Laryngeal mask airway
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N5
Registration date:2018-10-29, 1397/08/07
Registration timing:retrospective
Last update:2018-10-29, 1397/08/07
Update count:0
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
2018-03-11, 1396/12/20
Scientific title
Comparative evaluation of the efficacy of three different doses of atracurium on Laryngeal Mask Airway insertion conditions in patients undergoing phacoemulsification surgery
Public title
Effect of atracurium on Laryngeal Mask Airway insertion phacoemulsification
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cataract surgery by phacoemulsification
30 -50 years old
ASA 1 or 2
Exclusion criteria:
Poor mouth opening
Pharyngeal pathology
Laryngeal pathology
Pulmonary diseases
Risk of aspiration (full stomach, gastroesophageal reflux disease, pregnancy)
History of allergy to any anesthetic drugs"
High airway resistance
Age
From 30 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
An independent researcher creates random assignment cards using random computer numbers. Based on randomized sequencing, patients are enrolled in the study in three groupsRandom allocation cards are kept in an inaccessible location, in the end of the study these cards will be accessible for data analyzer
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of the dosage of the drug, and also to prevent blindness, the drugs were prepared by an anesthetist who was not during the study in the same syringes and encoded and given to the presenter for injection. The data was also collected by the project manager who was unaware of the dose of injectable drugs.
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
Hezarjarib Blvd, Isfahan University of Medical Sciences
The first attempt was made in 15 seconds and without the displacement = Easy, LMA In the first attempt needed more than 15 seconds, and need to LMA displacement = a bit of trouble, Need more than once trying to insertion of LMA, Need more than 30 seconds time And need to multiple LMA moves = quite difficult)
3
Description
Air leakage around LMA
Timepoint
once
Method of measurement
Yes = audible sound At the time of patient manual ventilation. No = Lack of sound at the time of patient manual ventilation.
4
Description
The number of attempts to insertion of laryngeal mask airway
Timepoint
During insertion of laryngeal airway mask
Method of measurement
The number
Secondary outcomes
1
Description
Move the limbs
Timepoint
During laryngeal mask insertion
Method of measurement
View and score based on Score 0 to 3
2
Description
Laryngospasm
Timepoint
During laryngeal mask insertion
Method of measurement
View and score based on Score 0 to 3
3
Description
Gagging
Timepoint
During laryngeal mask insertion
Method of measurement
View and score based on Score 0 to 3
4
Description
Cough
Timepoint
During insertion
Method of measurement
View and score based on Score 0 to 3
Intervention groups
1
Description
Intervention group: In this group after induction of anesthesia patients, receives atracurium at a dose of 0.2 mg/kg
Category
Treatment - Drugs
2
Description
Intervention group: In this group after induction of anesthesia patients, receives atracurium at a dose of 0.4mg/kg
Category
Treatment - Drugs
3
Description
Control group: In this group after induction of anesthesia patients, receives atracurium at a dose of 0.6 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faiz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Modares St
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2032
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy
Street address
Vice chancellor of research and technology of university.Isfahan Universuty of Medical Sciences.Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
https://reseach.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
Hamidreza Shetabi
Position
Assistant Proffessor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3668 8138
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital. Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3668 8138
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital. Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2034
Email
hamidshetabi@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available