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IRCT20230111057106N1 IRCT 2023-02-23 Guilan University Of Medical Sciences The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block: A randomized clinical trial 2023-01-21 anticipated 116 Complete https://irct.ir/trial/68014 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method of this study is based on four random blocks. According to the sample size, 27 random blocks are done through the Random Allocation software, and the patients are divided into two groups A (fentanyl-midazolam) and B (fentanyl - Propofol) based on the list of the sequence of random blocks according to the daily visits and having the inclusion criteria, are randomly assigned, Blinding description: The type of anesthesia is not explained to the patient. 3 catarct. Intervention 1: Intervention group: The intervention group receives a sedation with fentanyl 0.5g/kg and it is repeated for 5-10 minutes. After that, midazolam 0.01mg/kg - Hyalase patients also receive. Intervention 2: Intervention group: The intervention group received two sedation with fentanyl 0.5g/kg and repeated for 5-10 minutes - patients also received hyalase. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr Hassan behboudi
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
Rasht Iran (Islamic Republic of) 41396-37459 +98 13 3323 6886 behboudi_dr@yahoo.com Guilan University of Medical Sciences scientific Dr Hassan Behboudi
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
Rasht Iran (Islamic Republic of) 41396-37459 +98 31 3323 6886 behboudi_dr@yahoo.com Guilan University Of Medical Sciences Iran (Islamic Republic of) Unilateral cataract surgery patients aged 50-80 years with ASA class I, II elective surgery fasting patients surgeries performed under peribulbar block by an ophthalmologist with more than 25 years of experience 50 years 80 years Both ASA > 3 surgeries performed under other blocks or general anesthesia coagulation disorder use of antiplatelet drugs head tremor (Parkinson's) cognitive disorder Alzheimer's fear of closed spaces history of chronic cough addiction and history of use Analgesic drugs allergies to local anesthetic drugs non-cooperative patients H25.2 Age-related cataract, morgagnian type Treatment - Drugs Treatment - Drugs Intervention group: The intervention group receives a sedation with fentanyl 0.5g/kg and it is repeated for 5-10 minutes. After that, midazolam 0.01mg/kg - Hyalase patients also receive. Intervention group: The intervention group received two sedation with fentanyl 0.5g/kg and repeated for 5-10 minutes - patients also received hyalase. Degree of sedation using corrected Ramsay scale( RSS>3). Timepoint: Every 5 minutes. Method of measurement: Clinical examination. Patient satisfaction level. Timepoint: Evaluation of patients' satisfaction using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.between the end of surgery and transfer to the ward (recovery time). Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the way to set up the secondary variable of patient satisfaction can be a "five-point Likert scale". according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. Surgeon satisfaction level. Timepoint: Evaluation of surgen's satisfaction using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.between the end of surgery and transfer to the ward (recovery time). Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the method of setting up the secondary variable of surgeon satisfaction can be a five-point Likert scale. according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. Anesthesia complications. Timepoint: Anesthesia complications is evaluated using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. The time between the end of surgery and transfer to the ward (recovery time) is recorded. Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the secondary variable of anesthesia complications can be set up using a five-point Likert scale. according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. Recovery time. Timepoint: Recovery time is evaluated using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. The time between the end of surgery and transfer to the ward (recovery time) is recorded. Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block" the secondary variable of recovery time can be "five-point Likert scale". according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. Pain intensity. Timepoint: every 5 minutes. Method of measurement: clinical examination. Heart rate. Timepoint: every 5 minutes. Method of measurement: clinical examination. SpO2 percentage of arterial saturation. Timepoint: every 5 minutes. Method of measurement: clinical examination. Intraoperative pain. Timepoint: every 5 minutes. Method of measurement: clinical examination. Blood pressure. Timepoint: every 5 minutes. Method of measurement: clinical examination. Arterial blood pressure. Timepoint: every 5 minutes. Method of measurement: clinical examination. Guilan University Of Medical Sciences Approved 2022-12-07 Ethics committee of Guilan University of Medical Sciences Shahid Siadaty St., Namju St., Rasht Rasht Guilan Iran (Islamic Republic of)