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IRCT20220921056014N1 IRCT 2023-02-17 Sabzevar University of Medical Sciences Comparing the effects of dexmedetomidine and propofol in cataract surgery anesthesia Comparison of dexmedetomidine and propofol for maintenance anesthesia in cataract surgery 2022-11-22 anticipated 60 Complete https://irct.ir/trial/66264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done by the permutation block method. Blocks of six will be used. In this method, A and B represent the people who receive two interventions and C means the person who is placed in the control group. Considering the block of 6; AABBCC code 0, ABCABC code 1, ABCBAC code 2, BACABC code 3, BBCCAA code 4, and BACBA C code 5. Then, using the table of random numbers, we randomly choose a starting point and consider 10 numbers in a row or column. Therefore, by selecting 10 numbers from the table, it will be determined how to allocate a total of 60 people into 3 groups. Randomization tools are cards marked with three letters A, B, and C. Envelopes will be used to conceal the allocator from the type of card, Blinding description: Allocation of treatment is done by a person who is unaware of the treatment assigned to all three groups. In this case, cards are provided to the treatment allocator who is not aware of their content. The evaluation of the outcome will be done by a doctor who is not aware of the type of drug-assigned to each group (a doctor other than the treating doctor). In the data analysis, the help of the statistical consultant will be taken, who will not have any information about the type of treatment received by the people. Because during anesthesia, the person is exposed to the drug and is not aware of the type of injected drug, so even though part of the outcome is subjective (measured through VAS), there is no need to blind the patient. 2 Cataract surgery. Intervention 1: Control group: Routine treatment, which includes receiving the usual protocol (a combination of lidocaine with a dose of 1 mg/kg, atracurium with a dose of 0.3 mg/kg, and fentanyl with a dose of 1 mcg/kg) in the form of intravenous injection and then using a mask and LMA for patients, is done. Intervention 2: Intervention group 1: routine drugs of the control group plus dexmedetomidine drug with a dose of 1 mcg/KG. Intervention 3: Intervention group 2: routine drugs of the control group plus the drug propofol at a dose of 1 mg/kg. 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 Manijeh Yosefi Moghadam
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 ymanijeh@gmail.com Sabzevar University of Medical Sciences scientific Manijeh Yosefi Moghadam
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 ymanijeh@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) The need for cataract surgery Consent to participate in the study No other eye diseases No history of cataract surgery Lack of drug sensitivity Obtaining an anesthesiologist's license Not having underlying diseases At least 60 years old 60 years no limit Both Congenital cataract Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Routine treatment, which includes receiving the usual protocol (a combination of lidocaine with a dose of 1 mg/kg, atracurium with a dose of 0.3 mg/kg, and fentanyl with a dose of 1 mcg/kg) in the form of intravenous injection and then using a mask and LMA for patients, is done. Intervention group 1: routine drugs of the control group plus dexmedetomidine drug with a dose of 1 mcg/KG. Intervention group 2: routine drugs of the control group plus the drug propofol at a dose of 1 mg/kg. Blood pressure. Timepoint: 5 time periods including admission to the operating room, before anesthesia, immediately after, 15 minutes later, and during recovery. Method of measurement: Mercury pressure gauge. Respiratory Rate. Timepoint: 5 time periods including admission to the operating room, before anesthesia, immediately after, 15 minutes later, and during recovery. Method of measurement: Timer. Normal levels of oxygen saturation (SpO2). Timepoint: 5 time periods including admission to the operating room, before anesthesia, immediately after, 15 minutes later, and during recovery. Method of measurement: Pulse oximeter. Intensity of pain. Timepoint: 2 time periods before anesthesia, after consciousness in recovery. Method of measurement: Visual Pain Scale Questionnaire (VAS). Nausea, vomiting and dizziness. Timepoint: A period of time after surgery in recovery. Method of measurement: check list. Delirium. Timepoint: A period of time after surgery in recovery. Method of measurement: check list. The time it takes to wake up. Timepoint: A period of time after surgery in recovery. Method of measurement: check list. Sabzevar University of Medical Sciences Approved 2022-08-13 Ethics Committee of Sabzevar University of Medical Sciences Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)