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IRCT20180416039326N2 IRCT 2018-07-18 Esfahan University of Medical Sciences Relaxation of Ketamine Propofol and Fentanyl Propofol in Cataract Surgery Comparison of sedative efficacy of ketamine propofol 1 to 3 and fentanyl propofol in cataract surgery by phacoamulsification method 2017-03-21 anticipated 100 Complete https://irct.ir/trial/30904 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: , 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 Ketamine- propofol.Syringe 2 contains pethidine (0.2 mg / kg) with distilled water at a concentration of 5cc (concentration 10mg / cc). Propofol containing 0.6mg / kg Propofol (5mg / cc) and Propofol 4 (5mg / cc) will be administered. Group 1 (Kp) 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. Intervention 2: Intervention group: second: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 2 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.6 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. 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 No more information
public Hamidreza Shetabi
Feiz Hospital ، Modares St
isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ +98 31 3668 8138 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Morteza heidari
Faiz Hospital , Modares St
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ +98 31 3668 5555 m_heidari@med.mui.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing cataract surgery by phacoamulsification no limit no limit Both .History of any allergy to anesthetic drugs Congestive Heart Failure Cardiac arrest Glaucoma Hypotension Chronic respiratory disease Psychosis Schizophrenia H43.9 Unspecified disorder of vitreous body Treatment - Drugs Treatment - Drugs Intervention group: first: the combination of Ketamine- propofol.Syringe 2 contains pethidine (0.2 mg / kg) with distilled water at a concentration of 5cc (concentration 10mg / cc). Propofol containing 0.6mg / kg Propofol (5mg / cc) and Propofol 4 (5mg / cc) will be administered. Group 1 (Kp) 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. Intervention group: second: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 2 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.6 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. Sedation level based on ramsay score. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Ramsay score. Arterial pressure. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge. Heart rate. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Oximetry pulse. Surgeon Satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire. Percent saturation of oxygen. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Oximetry pulse. Esfahan University of Medical Sciences Approved 2017-12-16 Ethics committee of Isfahan Universiti of Medical Sciences Feiz Hospital . Modares st Isfahan Isfehan Iran (Islamic Republic of)