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IRCT20200510047389N2 IRCT 2020-05-19 Esfahan University of Medical Sciences The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group in Isfahan Feyz hospital from 2018-2019 2020-05-21 anticipated 210 Complete https://irct.ir/trial/48040 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided to three groups A, B, C in based on a simple random sampling by Random Allocation, Blinding description: In this double-blinded study the doctor and patient were unaware of type of medications and medications were prepared and encoded by anesthetist. 2-3 Condition 1: Cataract surgery. Condition 2: Tracheal intubation. Intervention 1: Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. Patients in this group received Dexmedetomidine at a dose of 1 mic/kg by slow infusion. Intervention 2: Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. The second group received Midazolam at a dose of 0.1 mg/kg by slow infusion. Intervention 3: Control group: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. In this group Normal Saline was given both volume and form with two previous medications. 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 informations
public Amir Beidokhti
Moshtagh St
Isfahan Iran (Islamic Republic of) 8158968886 +98 31 3260 3538 Amir.beidokhti71@gmail.com Esfahan University of Medical Sciences scientific Khosrou Naghibi
Feyz hospital., Modares St
Isfahan Iran (Islamic Republic of) 7346181764 +98 31 3668 5555 Naghibi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Elderly patients over 65 years old candidate for cataract surgery with general anesthesia ASA2-3 No allergy to any of the study medications 65 years no limit Both Hemodynamic changes over 30% that needed intervention Patient who refusing Severe drug complications History of using opioid and alcohol Changing the method of anesthesia Severe chronic disease H28 Y84.8 Cataract in diseases classified elsewhere Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Placebo Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. Patients in this group received Dexmedetomidine at a dose of 1 mic/kg by slow infusion Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. The second group received Midazolam at a dose of 0.1 mg/kg by slow infusion Control group: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. In this group Normal Saline was given both volume and form with two previous medications. Systolic Blood pressure. Timepoint: Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time. Method of measurement: Blood pressure monitoring device. Diastolic blood pressure. Timepoint: Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time. Method of measurement: Blood pressure monitoring device. Mean arterial Blood pressure. Timepoint: Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time. Method of measurement: Blood pressure monitoring device. Heart rate. Timepoint: Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time. Method of measurement: Monitoring device. Arterial oxygen saturation percentage. Timepoint: Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time. Method of measurement: Pulse oximetry. Surgery complictions. Timepoint: After the surgery in recovery. Method of measurement: Physical examination and observation by physician. Recovery time. Timepoint: After the surgery. Method of measurement: Minute. Esfahan University of Medical Sciences Approved 2019-03-18 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences., Hezarjarib Street Isfahan Isfehan Iran (Islamic Republic of)