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IRCT20180416039326N18 IRCT 2021-03-08 Esfahan University of Medical Sciences Comparison of the Effects of sublingual fentanyl and intravenous ketamine in phacoemulsification cataract surgery Comparison of the Effects of sublingual fentanyl and intravenous ketamine on pain control and hemodynamic variables in phacoemulsification cataract surgery under sedation and local anesthesia 2021-03-05 anticipated 86 Complete https://irct.ir/trial/54183 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the operating room, based on a random allocation software table , one of the compounds of sublingual fentanyl or intrvenous ketamine is given to patients, 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: In the sublingual fentanyl (SLF) group, fentanyl at a dose of 1.5µ / kg (up to 100 micrograms), which is reduced to 2 ml with normal saline, is administered sublingually to the patient. first 2 cc fentanyl (up to 100 micrograms) is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then 2 cc of normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus. Intervention 2: Control group: In intravenous ketamine (IVK) group, first 2 cc of normal saline is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then ketamine at a dose of 0.3 mg / kg which is reduced to 2 ml with normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus. Yes - There is a plan to make this available What will be shared: Unidentifiable individual data can be shared. When: 6 months after publication of paper To whom: Only available to scholars working in academic and academic institutions Conditions: Use for research and treatment purposes Where to obtain: Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir How to obtain: after request via email, it will be sent if available within a maximum of 1 month. Comments:
public Hamidreza Shetabi
Feyz hospital, Modares St
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8138 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Feyz hospital, Modarres St
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8138 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients aged 50-75 with ASA (American Society of Anesthesiology) class 1 and 2 that Candidates for phycoemulsification cataract surgery who are willing to enter the study 50 years 75 years Both History of any allergy or allergic reaction to any of medications used in the study pregnancy seizure or psychotic disorder preoperative hypotention Taking medication preoperatively (other than those mentioned before) Inflammation or any lesion of the oral cavity that interferes with sublingual administration of the drug increase intracranial pressure H26.9 Unspecified cataract Treatment - Drugs Treatment - Drugs Intervention group: In the sublingual fentanyl (SLF) group, fentanyl at a dose of 1.5µ / kg (up to 100 micrograms), which is reduced to 2 ml with normal saline, is administered sublingually to the patient. first 2 cc fentanyl (up to 100 micrograms) is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then 2 cc of normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus. Control group: In intravenous ketamine (IVK) group, first 2 cc of normal saline is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then ketamine at a dose of 0.3 mg / kg which is reduced to 2 ml with normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus. Sedation level based on ramsay score. Timepoint: every 5 minutes during surgery and then in recovery every 15 minutes, until discharge from recovery. Method of measurement: Ramsay score. Arterial blood pressure. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: pressure gauge. Oxygen saturation. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: Pulse oximeter. Heart rate. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: Pulse oximeter. Intensity of pain. Timepoint: in recovery every 15 minutes, until discharge from recovery. Method of measurement: Universal Pain assessment tool. Recovery time. Timepoint: After surgery until the discharge from the recovery. Method of measurement: Minute Numbers. Patient satisfaction. Timepoint: At the time of discharge from recovery. Method of measurement: Likert questionnaire. Surgeon satisfaction. Timepoint: after surgery. Method of measurement: Likert questionnaire. Adverse drug reaction. Timepoint: During surgery and in recovery. Method of measurement: Adverse drug reaction questionnaire. Isfahan University of Medical Sciences Approved 2020-05-02 Ethics committe of Isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services, Building No.4, Research and Technology Deputy of University,Hezar Jarib Street, Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)