Comparing the effects of remifentanil with fentanyl on pain intensity, hemodynamic status and post-anesthesia complications of cataract surgery candidate

Comparing the effects of remifentanil with fentanyl on pain intensity, hemodynamic status and post-anesthesia complications of cataract surgery candidate

This study will be conducted as a randomized clinical trial (blocks of four), double-blind, with parallel groups, without a control group, and phase 2-3, with the participation of 80 patients.

This study is a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups, without a control group and phase 2-3 and with the participation of 80 ERCP candidates referred to Imam Reza Hospital (Tabriz) will be done.

The criteria for entering the study include: ASA class I and II , candidates for cataract surgery and consent to participate in the study, and the exclusion criteria are: having diabetes or other endocrine disorders and using painkillers in the last 24 hours.

In the fentanyl group (group B), induction with 1 mg of midazolam, 0.7 micrograms per kilogram of body weight of fentanyl, 1 to 2 mg per kilogram of body weight of propofol along with 1 mg per kilogram of the patient's body weight Lidocaine and finally 10 mg of atracurium will be injected. In the remifentanil group (group A), induction with 1 mg of midazolam, 2 to 4 micrograms per kilogram of body weight of remifentanil, 1 to 2 mg per kilogram of body weight of propofol along with 1 mg per kilogram of body weight Lidocaine will be injected into the patient's body. Then, the speed of the onset of anesthesia and the complications after the surgery will be recorded in recovery.

Pain

In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B).

The statistical consultant and the patient will be unaware of the type of grouping in this plan; The final results will be delivered to the statistical consultant. Since the statistical consultant and the patients will not be aware of the grouping of the participants; Therefore, they are blind during the study.