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IRCT20180416039326N1 IRCT 2018-07-07 Esfahan University of Medical Sciences A comparative study on the effect of fentanyl-propofol and pethidine-propofol on sedation level during cataract surgery by phacoamulsification method Comparison of the effect of fentanyl-propofol and pethidine-propofol on the sedation level during cataract surgery by phacoamulsification method 2017-03-21 anticipated 80 Complete https://irct.ir/trial/31128 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The division of patients into two groups is based on a random number table, Blinding description: The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist who is unaware of the grouping of patients and is worn by an aluminum foil and encoded by an anesthetist.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping. 2 Cataract surgery. Intervention 1: Intervention group: first: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 1.5 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.4 mg / kg at 5 mg / cc and 4 Propofol, 5 mg / cc concentration. In group 1 (PF), the first syringe 1 is injected into the titre. Then, in each case, the syringe number 3 is injected into the titer of the sedation level of 3 or 4 ramsay. At the same time, if necessary, a deep sedation needing a syringe number 4 in 1 cc volumes is recorded as a dental carriage. Intervention 2: Intervention group: second: the combination of pethidine- propofol.Syringe 2 contains pethidine (0.6 mg / kg) with distilled water at a concentration of 5cc (concentration 10mg / cc). Propofol containing 0.4mg / kg Propofol (5mg / cc) and Propofol 4 (5mg / cc) will be administered. Group 2 pp) Firstly, the syringe 2 is injected into the header and then injected into the header 3 of the syringe 3 as a 3 or 4 sedation level of ramsay score. In the course of surgery, if you need a deeper sedation than Syringe 4 in 1cc volumes as the dose of salvage and total dose It is recorded. 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 a plan to make this available
public Hamidreza Shetabi
Feyz hospital, Modares St
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۶۴ +98 31 3668 8138 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Feyz hospital, Modares St
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۶۴ +98 31 3445 2034 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients aged 35 to 85 years Patients undergoing cataract surgery by phacoemulsification Patients undergoing local anesthetic sedation in the first and second classes of the American Anesthetic Association 18 years 90 years Both History of any allergy to the drug used in the design History of drug addiction, alcohol, benzodiazepine Pregnancy Congestive heart failure History of head trauma Glaucoma Hypotension Evidence of increased intracranial pressure Psychosis Schizophrenia Active upper respiratory tract infection Asthma Chronic respiratory disease H43.9 Unspecified disorder of vitreous body Treatment - Drugs Treatment - Drugs Intervention group: first: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 1.5 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.4 mg / kg at 5 mg / cc and 4 Propofol, 5 mg / cc concentration. In group 1 (PF), the first syringe 1 is injected into the titre. Then, in each case, the syringe number 3 is injected into the titer of the sedation level of 3 or 4 ramsay. At the same time, if necessary, a deep sedation needing a syringe number 4 in 1 cc volumes is recorded as a dental carriage. Intervention group: second: the combination of pethidine- propofol.Syringe 2 contains pethidine (0.6 mg / kg) with distilled water at a concentration of 5cc (concentration 10mg / cc). Propofol containing 0.4mg / kg Propofol (5mg / cc) and Propofol 4 (5mg / cc) will be administered. Group 2 pp) Firstly, the syringe 2 is injected into the header and then injected into the header 3 of the syringe 3 as a 3 or 4 sedation level of ramsay score. In the course of surgery, if you need a deeper sedation than Syringe 4 in 1cc volumes as the dose of salvage and total dose It is recorded. Sedation level based on ramsay score. Timepoint: Every 5 minutes during surgery. Method of measurement: Ramsay score. Arterial pressure. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: pressure gauge. Oxygen saturation. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter. Heart rate. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter. Intensity of pain. Timepoint: every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Universal Pain assessment tool. Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minute Numbers. Esfahan University of Medical Sciences Approved 2018-01-20 Ethics Committee of Isfahan University of Medical Sciences Isfahan Unoversity of medical sciences, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)