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IRCT20221108056442N1 IRCT 2022-11-26 Esfahan University of Medical Sciences Esmolol and Labetalol in cataract surgury in patient with chronic hypertension. A comparative study of labetalol and esmolol intravenous infusion in the prevention of cardiovascular complications and ischemic changes in patients with chronic hypertension during cataract surgery under local anesthesia with sedation 2022-12-22 anticipated 70 Complete https://irct.ir/trial/66759 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the simple randomization method of block randomization (block randomization) we will use. Blocking is usually in order Balance the number of samples assigned to each group To be used in the study. This feature helps researchers to Items that require intermediate analyzes during the sampling process The number of samples assigned to each of the case groups Study is equal. The size of all the blocks is equal and we are in this We will have a three-group trial of 6 blocks of 15. Randomization tools are also used in sequence generation software Random (software allocation Random) is used that Random sequence generation software in addition to simple randomization capable To generate random sequences by block generation method. For hiding We avoid concealment allocation We use the method used to execute the sequence Random refers to study participants, in a way That before the individual is assigned, the assigned group is not specified. With From opaque envelopes sealed in random sequence (envelopes opaque, sealed, numbered Sequentially) in This method uses each of the random sequences created on a card It is registered and the cards are placed in the letter envelopes in order To be. In order to maintain a random sequence, also on the outer surface of the envelope The numbering is done in the same way. Finally the envelope lid The letters are pasted and placed in a box, respectively. At Time to start registration of participants, based on the order of entry of the company Eligible applicants to open one of the envelopes in order And the assigned group of the participant will be revealed, Blinding description: The researcher, patients and project partner who will perform the statistical analysis will not be aware of the study (triole blind). The grouping of patients will be recorded on a sheet and given to one of the project colleagues. Patients will receive the standard treatment, but they will not know the type of medicine received. 3 Cardiovascular complications and ischemic changes in patients with chronic hypertension during cataract surgery. Intervention 1: Intervention group:0.5 mg/kg of intravenous osmolol, whose volume will be increased to 20 cc by sterile normal saline, 5 minutes before the injection of sedative and sedative drugs and will be intravenously infused within two minutes. Intervention 2: Intervention group: 0.2 mg/kg body weight of intravenous labetalol, whose volume will be increased to 20 cc by sterile normal saline, will be intravenously infused within two minutes 5 minutes before the injection of sedative and sedative drugs. Yes - There is a plan to make this available What will be shared: Information related to the effectiveness of esmolol and labtalol in reducing cardiovascular complications in cataract surgery candidates with chronic hypertension. When: Start the access period up to one year after the results are published To whom: Researchers Conditions: Can be used for secondary studies Where to obtain: Correspond with dmoradi@med.mui.ac.ir How to obtain: Will be sent after receving the email Comments:
public Darioush Moradi Farsani
Block 8 , Kouye Bahar , Hezarjerib St
Esfahan Iran (Islamic Republic of) 8169615738 +98 31 4754 7767 Dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Darioush Moradi Farsani
Block 8 , Kouye bahar , Hezarjerib St
Esfahan Iran (Islamic Republic of) 8169615738 +98 31 4754 7767 Dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate patients for cataract surgery Patients over 65 years old 65 years no limit Both History of drug allergy Addiction Prevention Prevention Intervention group:0.5 mg/kg of intravenous osmolol, whose volume will be increased to 20 cc by sterile normal saline, 5 minutes before the injection of sedative and sedative drugs and will be intravenously infused within two minutes. Intervention group: 0.2 mg/kg body weight of intravenous labetalol, whose volume will be increased to 20 cc by sterile normal saline, will be intravenously infused within two minutes 5 minutes before the injection of sedative and sedative drugs. Heart Rate. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: Cardiac Monitor device. Systolic Blood Pressure. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: In millimeteres of mercury using a Calibrated Barometer. Diastolic Blood pressure. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: In millimeteres of mercury using a Calibrated Barometer. Percentage of oxygen Saturation. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: Pulse oximeter. Hypertension. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: In millimeteres of mercury using a Calibrated Barometer. Hypotension. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: In millimeteres of mercury using a Calibrated Barometer. Tachycardia. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: Cardiac Monitor device. Bradycardia. Timepoint: Before the start of the operation, 5 minutes after the start of the operation, every 15 minutes until the end of the operation. Method of measurement: Cardiac Monitor device. Esfahan University of Medical Sciences Approved 2022-11-08 Ethics committee of Isfahan University of Medical Sciences Block 8 , Hezarjerib Ave , Bahar St Esfahan Isfehan Iran (Islamic Republic of)