Preoperative hemodynamic Changes after Continuing or discontinuing Regular Angiotensin Converting Enzyme Inhibitors before Cataract Surgery a Comparative Study
Perioperative hemodynamic Changes after Continuing or discontinuing Regular Angiotensin Converting Enzyme Inhibitors before Cataract Surgery a Comparative Study
Design
Double blinded randomized clinical trial
Settings and conduct
200 patients in the Khalili Hospital of Shiraz with choronic use of ACEI (Angiotensin Converting Enzyme Inhibitors) or ARB (Angiotensin Receptor Blocker)Intervention group: Chronic ACEI users who do not stop their medication until the surgery. Control group: Chronic ACEI users who discontinue their medication 24 to 12 hours before the surgery. are divided into two groups.
Participants/Inclusion and exclusion criteria
ASA II Patients who are undergoing Cataract Surgery Ejection fraction higher than 40 % Patients with chronic use of ACEI or ARB.
Intervention groups
Intervention group: Chronic ACEI users who do not stop their medication until the surgery. Control group: Chronic ACEI users who discontinue their medication 24 to 12 hours before the surgery.
Main outcome variables
The patient's initial blood pressure will be recorded after entering the operating room and then every 5 minutes after induction of anesthesia and during the operation. In the recovery room, blood pressure will be checked every 10 minutes for 1 hour. The patient's initial heart rate will be recorded after entering the operating room and then every 5 minutes after induction of anesthesia and during the operation. In the recovery room, heart rate will be checked every 10 minutes for 1 hour.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N78
Registration date:2019-04-06, 1398/01/17
Registration timing:prospective
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preoperative hemodynamic Changes after Continuing or discontinuing Regular Angiotensin Converting Enzyme Inhibitors before Cataract Surgery a Comparative Study
Public title
Preoperative hemodynamic Changes after Continuing or discontinuing Regular Angiotensin Converting Enzyme Inhibitors before Cataract Surgery a Comparative Study
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
ASA II
Patients who are undergoing Cataract Surgery
Ejection fraction higher than 40 %
Patients with chronic use of ACEI (Angiotensin Converting Enzyme Inhibitors) or ARB(Angiotensin Receptor Blocker) .
Exclusion criteria:
Duration of operation more than 90 min
Electrolyte imbalance
Liver or Kidney dysfunction
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly enter the study through the randomization chart which is derived from the www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
The code and group name of each patient will be placed in a separate envelope and sealed and is delivered to the person who is responsible for the anesthetic of the operating room. He is the only person who is aware of the study group of each patient and will not be involved in other parts of the implementation and data collection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-08-24, 1397/06/02
Ethics committee reference number
IR.SUMS.MED.REC.1397.404
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Blood pressure
Timepoint
The patient's initial blood pressure will be recorded after entering the operating room and then every 5 minutes after induction of anesthesia and during the operation. In the recovery room, blood pressure will be checked every 10 minutes for 1 hour.
Method of measurement
Pressure cuff
2
Description
Heart Rate
Timepoint
The patient's initial heart rate will be recorded after entering the operating room and then every 5 minutes after induction of anesthesia and during the operation. In the recovery room, heart rate will be checked every 10 minutes for 1 hour.
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Chronic ACEI users who do not stop their medication until the surgery.
Category
Diagnosis
2
Description
Control group: Chronic ACEI users who discontinue their medication 24 to 12 hours before the surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
khalili Hospital
Full name of responsible person
Saeed Khademi
Street address
khalili Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134842119
Phone
+98 71 3647 4270
Email
namazi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ghadimi
Position
متخصص بیهوشی
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 36474270
Email
maryam_ghadimi2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeed Khademi
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 36474270
Email
khademish@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.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