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IRCT20141209020258N156 IRCT 2021-04-25 Arak University of Medical Sciences Comparison of sedation and hemodynamic changes resulting from administration of ‎dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by ‎Phacoemulsification method Comparison of sedation and hemodynamic changes resulting from administration of ‎dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by ‎Phacoemulsification method 2021-05-05 anticipated 128 Complete https://irct.ir/trial/55545 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random allocation with envelopes in4 groups A and B and C and D. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. 3 Cataract surgery. Intervention 1: Intervention group: Dexmedetomidine is administered intravenously at a dose of 0.5 μg / kg. (Madonex ampoule 100 micro grams per millilitre made by Exir Pharmaceutical Company - Iran). Intervention 2: Intervention group: 0.1 mg / kg of Etomidate is given to patients. (Made by Abureihan Pharmaceutical Company - Iran). Intervention 3: Intervention group: 0.5 mg / kg ketamine is administered intravenously. (Made by Rotex Medica - Germany) (Rotexmedica GmbH Arzneimittelwerk). Intervention 4: Control group: Receive routine treatment with placebo. 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 more information
public Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate for cataract surgery by Fico method Age 35 to 85 years Absence of mental disorders Lack of history of chronic use of sedatives No alcohol and drugs Absence of severe obstructive pulmonary disease and asthma No history of heart disease, heart block and bradycardia Absence of systolic blood pressure less than 90 mm Hg Absence of severe liver and renal failure Absence of uncontrolled diabetes Absence of cerebrovascular diseases 35 years 85 years Both Patient dissatisfaction H25 Age-related cataract Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine is administered intravenously at a dose of 0.5 μg / kg. (Madonex ampoule 100 micro grams per millilitre made by Exir Pharmaceutical Company - Iran) Intervention group: 0.1 mg / kg of Etomidate is given to patients. (Made by Abureihan Pharmaceutical Company - Iran) Intervention group: 0.5 mg / kg ketamine is administered intravenously. (Made by Rotex Medica - Germany) (Rotexmedica GmbH Arzneimittelwerk) Control group: Receive routine treatment with placebo. Sedation. Timepoint: Every 5 minutes during surgery and in recovery and 1, 2 and 4 hours after surgery. Method of measurement: Ramsay score. Pain. Timepoint: During surgery every 5 minutes and during recovery and 1, 2 and 4 hours after surgery. Method of measurement: Visual analog pain score. Arak University of Medical Sciences Approved 2021-03-03 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)