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IRCT20190325043107N35 IRCT 2023-09-01 Tabriz University of Medical Sciences Efects of remifentanil with fentanyl on pain intensity, hemodynamic status and post-anesthesia complications Comparing the effects of remifentanil with fentanyl on pain intensity, hemodynamic status and post-anesthesia complications of cataract surgery candidate 2023-09-20 anticipated 80 Complete https://irct.ir/trial/72211 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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), Blinding description: 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. 2-3 Pain. Intervention 1: Intervention group: 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. Intervention 2: Control group: 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. Then, the speed of the onset of anesthesia and the complications after the surgery will be recorded in recovery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) ASA class I and II Candidate for cataract surgery Consent to participate in the study 18 years 65 years Both Having diabetes or other endocrine disorders Use of painkillers in the last 24 hours G89.11 Acute pain due to trauma Prevention Prevention Intervention group: 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. Control group: 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. Then, the speed of the onset of anesthesia and the complications after the surgery will be recorded in recovery. Pain. Timepoint: Once every hour and for six hours after the end of anesthesia. Method of measurement: Visual Analog Scale. Tabriz University of Medical Sciences Approved 2023-08-22 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)