IRCT2013072911676N2 IRCT 2013-10-09 Vice chancellor for Research, Tehran University of Medical Sciences and Health Services Effect of midazolam-fentanyl versus propofol-ketamine sedation for peribulbar nerve block Comparison of midazolam-fentanyl versus propofol-ketamine sedation for peribulbar nerve block 2013-08-13 anticipated 70 Complete https://irct.ir/trial/11847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Sedation in peribulbar block cataract surgery. Intervention 1: Intervention group (group pk): A minidose of lidocaine (10mg) for local anesthesia of the vein endothelium was injected through the Intravenous catheter 1 min before the injection of propofol. The assigned study drug was administered in the dose of 0.03 mL/kg (maximum 2.5 mL) as a bolus. Additional study drug was then administered in 0.5-mL increments 15 s apart until the patients’ eyes closed and they were unresponsive to the verbal command “open your eyes.” The volume of study drug administered up to this point was termed the “hypnotic dose.” Hypnotic dose and supplemental dose of the study drug were recorded. If the patient exhibited grimacing and/or extremity movement requiring restraint, further needle insertion was withheld. Supplemental study drug was then administered in 0.5- to 1 mL increments at 10- s intervals until little or no patient movement and/or grimacing occurred with the advancement of the needle.(max dose 5 ml ). Intervention 2: Control group(group mf):The patients received either 1 microg/kg of fentanyl and 0.02 mg/kg of midazolam by bolus IV injection 1 minute before the administration of a PRBB. At the discretion of the anesthesiologist, intraoperative sedation consisting of 1-mL increments of the study drug or 0.5-mL increments of midazolam ( 1 mg/mL; maximal dose 2 mg) or fentanyl (50 mg/ mL; maximal dose 2 mL) could be administered to keep the patient comfortable but awake and responsive.