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IRCT20160307026950N12 IRCT 2019-06-06 Esfahan University of Medical Sciences The effects of midazolam and dexmedetomidine in patients under stereotaxic surgery Comparison of the effects of midazolam and dexmedetomidine on sedation levels, hemodynamics and complications in patients under brain stereotaxic surgery 2017-09-23 anticipated 64 Complete https://irct.ir/trial/39198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients randomly assigned to two different groups A and B with Random Allocation computer software, Blinding description: patients and anesthetic technician did not know about administering drugs. 3 Condition 1: respiratory apnea. Condition 2: systolic and diastolic blood pressure. Condition 3: heart rate. Condition 4: drug sedation level. Condition 5: bleeding. Condition 6: oxygen saturation level. Intervention 1: Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. Patients in this group received midazolam at a dose of 1 mg/kg IV bolus. Intervention 2: Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. The second group received intravenous dose of 1 mcg/kg/min of dexmedetomidine. 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 further information
public mehdi khademi
shariati street
khorram abad Iran (Islamic Republic of) 6818795459 +98 66 3330 9832 mehdi.kh199271@gmail.com Esfahan University of Medical Sciences scientific Dr. Behzad Nazemroaya
Department of Anesthesiology, AL-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) patients candidates brain stereotaxic surgery age between 18 and 60 No history of allergic reaction to both midazolam and dexmedetomidin 18 years 60 years Both any change in anesthesia or surgery plan due to any complication patient expiration during surgery R06.81 I95.2 R00.1 Y47 T81.0 R09.0 Apnea, not elsewhere classified Hypotension due to drugs Bradycardia, unspecified Sedatives, hypnotics and antianxiety drugs Haemorrhage and haematoma complicating a procedure, not elsewhere classified Asphyxia and hypoxemia Treatment - Drugs Treatment - Drugs Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. Patients in this group received midazolam at a dose of 1 mg/kg IV bolus. Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. The second group received intravenous dose of 1 mcg/kg/min of dexmedetomidine. Systolic and diastolic blood pressure. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Non-invasive barometer. Heart rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: pulse oximetry device. Respiratory rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Count in minute. Drug sedation level. Timepoint: after end of surgery. Method of measurement: Ramsay sedation scale. Patient satisfaction. Timepoint: after end of surgery. Method of measurement: Visual Analogue Scale. Surgeon satisfaction. Timepoint: after end of surgery. Method of measurement: Iowa Satisfaction with Anesthesia Scale. Recovery time. Timepoint: From the moment of finishing surgery to full recovery time. Method of measurement: In minute using a chronometer. Bleeding. Timepoint: after end of surgery. Method of measurement: Bleeding above 50 cc. Low blood oxygen saturation. Timepoint: during surgery. Method of measurement: The drop in oxygen saturation below 90% by pulse oximeter. Respiratory apnea. Timepoint: during surgery. Method of measurement: Respiratory arrest for more than 8 seconds measured by chronometer. Esfahan University of Medical Sciences Approved 2019-03-16 Ethics committee of Isfahan University of Medical Sciences Hezarjarib street isfahan Isfehan Iran (Islamic Republic of)