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IRCT20170809035601N7 IRCT 2018-08-28 Esfahan University of Medical Sciences Propofol-Ketamine versus Midazolam-Ketamine for sedation in patients undergoing cataract surgery by phacoamulsification method. Comparison of the effect of ketamine-propofol and ketamine-midazolam on the sedation level during cataract surgery by phacoamulsification method 2017-12-02 anticipated 68 Complete https://irct.ir/trial/30421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the operating room, patients are assigned to either midazolam ketamine or propofol ketamine based on a random number table, Blinding description: The patient and the researcher are not aware of the type of medication used.Medications are prepared by an anesthetic expert who has no role in the study and then injected by an anesthetist to each patient group. The person who records the data is also unaware of the type of medication used. 2 Cataract surgery. Intervention 1: Intervention group: 0.5 mg/kg Ketamine with 1 mg/kg propofol in a syringe titre is injected. In case of need, 20 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose is recorded. Intervention 2: Intervention group: 0.05 mg/kg Midazolam with 0.5 mg/kg Ketamine in a syringe titre is injected. In case of need, 25 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose 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
Department of Anesthesia, Al-Zahra Medical Center, Sofe Avenue
Isfahan Iran (Islamic Republic of) 8174675731 +98 313668555 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for cataract surgery. Patients who are satisfied to enter the study. Patients aged 30-88 years. 30 years 88 years Both History of allergy or allergic reaction to any of the medication used in the study. History of head injuries. High intraocular pressure or intracranial pressure. Cardiovascular risk. Severe respiratory disease. Advanced epilepsy or history of seizure or neurological disorder. The presence of any tumor or brain metastasis. Use of any analgesic and anesthetic drug. H26.9 Unspecified cataract Treatment - Drugs Treatment - Drugs Intervention group: 0.5 mg/kg Ketamine with 1 mg/kg propofol in a syringe titre is injected. In case of need, 20 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose is recorded. Intervention group: 0.05 mg/kg Midazolam with 0.5 mg/kg Ketamine in a syringe titre is injected. In case of need, 25 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose is recorded. Sedation level. Timepoint: After induction of anesthesia, during the procedure every 5 minutes. Method of measurement: Modified Ramsay Sedation Scale(RSS). Mean Arterial Pressure. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: pressure gauge. Heart rate. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter. Arterial oxygen saturation. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter. Intensity of pain. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Universal Pain assessment tool. Frequency of complications. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Adverse drug reaction questionnaire. Recovery time. Timepoint: After completing the procedure until the exit from the recovery. Method of measurement: Minute Numbers. Surgeon Satisfaction. Timepoint: During the procedure. Method of measurement: Likert scale. Esfahan University of Medical Sciences Approved 2017-12-31 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services,Building No. 4, Research and Technology Deputy of University, Hazar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)