The comparison intraocular pressure changes in patients that candidate for cataract surgery with local anesthesia and general anesthesia with laryngeal mask airway and variety of laryngoscopy
Comparison of intraocular pressure changes in patients undergoing cataract surgery under local anesthesia and general anesthesia with laryngeal mask airway and types of laryngoscopy.
Comparison of hemodynamic changes (systolic, diastolic and mean arterial blood pressure) in patients undergoing cataract surgery under local anesthesia and general anesthesia with laryngeal mask airway and laryngoscopy types.
Design
A clinical trial with a control group, with 5 parallel group, double-blind, randomized
Settings and conduct
The study of hemodynamic stress in 5 groups patients in operating room of Moradi Hospital in Rafsanjan was performed. Patient and data analyst did not know the effect of methods on hemodynamics.
Participants/Inclusion and exclusion criteria
Patients referring to operating room of Moradi hospital in Rafsanjan for elective cataract surgery in 2018-19
Intervention groups
Intubation with Macintosh Direct Laryngoscope with Blade 3
Intubation with McCoy Direct Laryngoscope with Blade 3
Intuition with glideoscope with blade 3
Laryngeal mask airway embedded in the classical way
The comparison intraocular pressure changes in patients that candidate for cataract surgery with local anesthesia and general anesthesia with laryngeal mask airway and variety of laryngoscopy
Public title
The comparison intraocular pressure changes in patients that candidate for cataract surgery with local anesthesia and general anesthesia with laryngeal mask airway and variety of laryngoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
40 to 80 years old
Candidate of Elective Cataract Surgery by Phacoemulsification
ASA Class 1 and 2
Exclusion criteria:
Cardiovascular, respiratory, neovascular, coagulopathy disease
High risk for aspiration
History of difficult Intubation
Likely probability of difficult intubation in clinical examination
Aspiration and vomiting during induction of anesthesia
Cardiac arrest during induction of anesthesia, laryngoscopy and surgery
Use of sedative over the past 24 hours
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
170
Actual sample size reached:
170
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, 170 cards were prepared in 5 groups of 34 groups A, B, C, D, E and each patient randomly selected one of the cards and entered the corresponding group.
Blinding (investigator's opinion)
Double blinded
Blinding description
At first, for the participants, 5 groups were explained and after consent, Patients were included in the study, while they were randomly selected and the outcome was not known.
The person who carried out the outcome evaluation used different methods and its effect on the outcome was not known.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Koye Asatid., Sarallah Ave., Emam Blvd., Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7716614697
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.RUMS.REC.1396. 149
Health conditions studied
1
Description of health condition studied
Changes in intraocular pressure and hemodynamics
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
hemodynamic Changes
Timepoint
Before the intervention, immediately after the intervention, five minutes after the intervention
Method of measurement
Arterial pressure is measured through an automatic pressure gauge (SAADAT model) and heart rate (via ECG).
Secondary outcomes
1
Description
Intraocular pressure changes
Timepoint
Before the intervention, immediately after the intervention, five minutes after the intervention
Method of measurement
Tonopon Tonometer
Intervention groups
1
Description
Intervention group: Intubation is performed with a Macintosh direct laryngoscope with blade 3.
Category
Prevention
2
Description
Intervention group: Intubation is performed with the McCoy Direct Laryngoscope with Blade 3.
Category
Prevention
3
Description
Intervention group: Intubation is performed with a glideoscope with a blade 3.
Category
Prevention
4
Description
Intervention group: The laryngeal mask AIRWAY is embedded in a classic way.
Category
Prevention
5
Description
Control group: Local anesthetic with 0.5% tetracaine drops
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Moradi hospital
Full name of responsible person
Asma Amiri
Street address
Shohada Ave., Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7861755763
Phone
+98 34 3325 6563
Email
asma.amirid@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza motamedi
Street address
Ali ebn Abitaleb Hospital, Imam Ali Blvd, Rafsanjan City
City
Rafsanjan
Province
Kerman
Postal code
7716614697
Phone
+98 34 3428 0006
Email
asma.amirid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Asma Amiri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali ibn Abi Talib Hospital., Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7716614697
Phone
+98 34 3428 0006
Email
asma.amirid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Asma Amiri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali ibn Abi Talib Hospital., Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7716614697
Phone
+98 34 3428 0006
Email
asma.amirid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Asma Amiri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali ibn Abi Talib Hospital., Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7716614697
Phone
+98 34 3428 0006
Email
asma.amirid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD