Comparison Of Anesthesia With Sevoflurane Versus Propofol On The Extubation Time And Recovery Parameters In The Patients Undergoing Cataract Surgery In Shahid Mohammadi Hospital
Comparison Between Sevoflurane And Propofol on Extubation Time And Rrecovery Parameters In Cataract Surgery
Design
Randomized three-blind clinical Trial with parallel groups designed with 60 patients from 23-05-2020 to 24-08-2020.
Settings and conduct
This Study will perform in shahid Mohammadi Hospital in Bandar-e Abas. The patient enters the study with written consent and doesn't know which group she/he will be study. The person who evaluates the patient in recovery does not know how the patient is anesthetized group. ( case or control)
Participants/Inclusion and exclusion criteria
Inclusion criteria:The Patients with 18- 75 Years Old Candidates for Cataract Surger ASA 1- 2
Exclusion Criteria: ASA 3- Urgent surgery- Co- Existing Surgery With Cataract eg, Glucoma- Hepatic Failure- Renal Failure- Drug Sensitivity- Obesity ( BMI>30)
Intervention groups
This prospective clinical trial study will be performed on 60 patients 18-75 years old with ASA 1and 2 who candidate for cataract surgery. Patients will randomly divided to two groups (30 patients each group). In the first group anesthesia will maintain with propofol 100 µg / kg / min and in the second group, sevoflurane( 0. 5- 1.5% ).
Demographic data, hemodynamic parameters, surgical characteristics, pain severity and patient satisfaction will record. Data will analyzed by statistical tests and P <0.05 will be considered significant.
Main outcome variables
Extubation Time- Awakening Time- Nausea and Vomiting- Postoperative Pain- Postoperative Blood Pressure- Heart Rate- Discharge time from Recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200425047194N1
Registration date:2020-11-11, 1399/08/21
Registration timing:retrospective
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Abdorasoul Anvaripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3333 1925
Email address
a.anvaripour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2020-08-24, 1399/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Anesthesia With Sevoflurane Versus Propofol On The Extubation Time And Recovery Parameters In The Patients Undergoing Cataract Surgery In Shahid Mohammadi Hospital
Public title
Comparison Between Propofol And Sevoflurane on Recovery From Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for Cataract Surgery
No History of Systemic Disease
Controlled with a History of Systemic Disease
Exclusion criteria:
Obesity With BMI More Than 30
Urgent Surgery
Uncontrolled Systemic disease With Complication
Renal Failure
Hepatic Failure
Complex Eye Surgery With Cataract Surgery eg. Glucoma
Drug Sensitivity
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients to whom the inclusion criteria apply are randomly divided into two groups using the table obtained by Random Allocation Software. This software creates a random sequence by blocking. Each patient participating in the study will receive a unique code and the person performing the randomization with the software will not be aware of the next steps and interventions. After assigning the code, patients will be divided into two groups. Then, to maintain anesthesia, the first group is given Propofol and the second group is given Sevoflurane.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient enters the study with written consent and doesn't know which group she/he will be study. The person who evaluates the patient in recovery does not know how the patient is anesthetized group. ( case or control)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences Ethics Commity
From the hold of Anesthetic Drugs to Patient Verbal stimulation Response
Method of measurement
Eye Opening
3
Description
Nausea and Vomiting
Timepoint
Recovery Room
Method of measurement
Marshal Criteria
4
Description
Post Operative Pain
Timepoint
Recovery Room
Method of measurement
Visual analogue Scale
5
Description
Postoperative Blood Pressure
Timepoint
Recovery Room
Method of measurement
Non Invasive blood Pressure
6
Description
Sedative Status
Timepoint
Recovery Room
Method of measurement
Ramsay Scale
7
Description
Heart Rate
Timepoint
Recovery Room
Method of measurement
Monitoring
8
Description
Saturation of Peripheral Oxygenation
Timepoint
Recovery Room
Method of measurement
Monitoring
9
Description
Discharge Time From Recovery
Timepoint
Recovery Room
Method of measurement
Marshal Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In patients in the first group, Propofol at a concentration of 10 mg/cc is used as an intravenous infusion of 100μg/kg/min to maintain anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group of patients, Sevoflurane is used in the amount of 0.5-1.5% by inhalation to maintain anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Hashem Jarineshin
Street address
Jomhurye Eslami Blv
City
Bandar-e -Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Hjarineshin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Agha Mollaei
Street address
Jomhurye Eslami Blv, Shahid Mohammadi Hospital
City
Bandar -e- Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhurye Eslami Blv, Shahid Mohammadi Hospital, Bandar- e Abbas
City
Bandar-e Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhurye Eslami Blv, Shahid Mohammadi Hospital
City
Bandar- e- Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Abdorasoul Anvaripour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Ave, Heart Hospital
City
Bushehr
Province
Boushehr
Postal code
7513934698
Phone
+98 77 3333 1925
Email
a.anvari.p@hotmail.com
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