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

If it is determined that each of the drugs esmolol and labtalol by intravenous injection method are more effective in preventing cardiovascular complications in patients with chronic hypertension during cataract surgery by local anesthesia and sedation, they can be used routinely.

Clinical trial without control group, with parallel group, triple blinde, randomized, phase 3 on 70 patients, random allocation software was used for randomization.

A triple blind clinical trial in patients with chronic hypertension who are candidates for cataract surgery. The Patients will be under local anesthesia with sedation, and then 5 minutes before the surgery, the first group will be treated with osmolol and the second group will be treated with labtalol, and during the operation, the vital signs of both groups will be recorded and examined. The above study is conducted in Faiz Medical Center

Patients who will be included in the study: 1- Candidate patients for cataract surgery with local anesthesia and sedation based on ASA III-II criteria 2-Patients over 65 years of age and of both sexes with chronic hypertension treated with calcium channel blockers and angiotensin converting enzyme inhibitors Patients who are not eligible for the study: 1-Patients who have a history of drug allergy 2-Patients who have addictions.

In the first group, 0.5 mg/kg intravenous osmolol, whose volume will be increased to 20 cc by sterile normal saline, will be intravenously infused within two minutes, then in the second group, 0.2 mg/kg intravenous labetalol, whose volume will be increased to 20 cc by sterile normal saline. 20 cc will be delivered and will be intravenously infused within two minutes.

Systolic blood pressure, diastolic blood pressure, heart rate, breathing rate, arterial oxygen saturation

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.

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.

Information related to the effectiveness of esmolol and labtalol in reducing cardiovascular complications in cataract surgery candidates with chronic hypertension.

Start the access period up to one year after the results are published

Researchers

Can be used for secondary studies

Correspond with dmoradi@med.mui.ac.ir

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