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IRCT20110528006617N6 IRCT 2021-07-07 Esfahan University of Medical Sciences The effect of oral zolpidem on hemodinamic indicies and the patients Equlibrium in Stereotaxic surgeries. Survery of the effect of oral zolpidem on hemodinamic signs and the patients Equlibrium in Stereotaxic surgeries. 2021-07-10 anticipated 64 Complete https://irct.ir/trial/57316 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random function "Random Number Generation " of Excel software based on patient file number will be used for randomization. Patients file number were entered into Excel program and patients were divided into case and control groups based on the random button. In total, there were two groups of 64 people. In this case, the file number is entered in Excel program, then a random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 32 people in each group. As a result, sequences 1 to 2 should be repeated 32 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 32 for repeating the sequence. In this way, 64 units will be produced, Blinding description: We produced tablet similar to Zolpidem,The once group received one tablet of Zolpidem 1 hour before surgery and the second group received one tablet of Placebo 1 hour before surgery. So the patients do not have any information about the intervention and the person who registered the information do not know which patient in which group ist and the study has two blind side. 3 General anesthesia. Intervention 1: Intervention group: Initially,personal consent is obtained from the patients.This group receive 10 mg tablet of zolpidem 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil . Intervention 2: Control group: Initially,personal consent is obtained from the patients.This group receive tablet of placebo 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil . 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 further Information is available.
public Mehrdad Masoudifar
Alzahra Hospital, Sofe Blvd, Shahid Keshvari highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Masoudifar
Alzahra hospital, Sofe Blvd, Shahid Keshvari highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 20 – 65 years old Patients who consent to the informed consent to participate in the study ASA class 1,2 20 years 65 years Both Use of sedative drugs Addiction to Alcohol Allergic reaction to drug Parkinsons disease Obstructive sleep apnea Patients who have bradycardia T88.5 Other complications of anesthesia Treatment - Drugs Placebo Intervention group: Initially,personal consent is obtained from the patients.This group receive 10 mg tablet of zolpidem 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil . Control group: Initially,personal consent is obtained from the patients.This group receive tablet of placebo 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil . Systolic blood pessure. Timepoint: Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery. Method of measurement: Mm-hg, sphygmomanometer. Diastolic blood pressure. Timepoint: Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery. Method of measurement: Mm-hg, sphygmomanometer. Heart rate. Timepoint: Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery. Method of measurement: ECG monitor. Mean arterial pressure. Timepoint: Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery. Method of measurement: Mm-hg, sphygmomanometer. O2 saturation. Timepoint: Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery. Method of measurement: O2 saturation percentage , pulse oximeter device. Surgeon Satisfaction. Timepoint: End of the surgery. Method of measurement: Likert Scale. Patient Satisfaction. Timepoint: End of the surgery. Method of measurement: Likert Scale. Esfahan University of Medical Sciences Approved 2020-10-26 Ethics committee of Isfahan University of Medical sciences Isfahan University Of Medical Science, Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)