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IRCT20210415050976N2 IRCT 2021-05-25 Jahrom University of Medical Sciences midazolam with dexmedetomidine for ‎extubation Comparison of the effect of midazolam with dexmedetomidine before ‎extubation on anesthesia emergence reactions in patients after lumbar disc ‎surgery: a randomized clinical trial study 2021-05-22 anticipated 90 Complete https://irct.ir/trial/56262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients participating in the present study will be divided into three groups of dexmedetomidine, midazolam and control by throwing dice, Blinding description: After preparation, the drugs are placed in a special box in a syringe and delivered to the relevant anesthesiologist. The anesthesiologist is already aware of the grouping of studies and the safety of injecting all three available box models (three study groups) but does not know the contents of the received box. There will be no difference in how the contents of the three study boxes are injected. Only the anesthesia supervisor will be notified of the coding of the boxes. The outcome assessor will have no information about the type of drug. 2-3 Lumbar disc surgery. Intervention 1: Intervention group 1: Patients in group 1 will receive midazolam 20 minutes before extubation at a dose of 20. mg per kg of body weight. Intervention 2: Intervention group 2: Patients in group 2 will receive dexmedetomidine 20 minutes before extubation at a dose of 1 mg per kg body weight. Intervention 3: Control group: Patients in the control group will receive normal saline 20 minutes before extubation. Yes - There is a plan to make this available What will be shared: At the reasonable request of the person in charge of this project, the data obtained from the project will be available. When: After the publication of the article or dissertation resulting from this research To whom: People who send their request to the person in charge of this project. Conditions: After the publication of the article or dissertation of this study, the data of this research will be available to researchers who intend to conduct meta-analytical review studies. Where to obtain: If the request is sent by email to the person in charge of this research, the request will be reviewed. How to obtain: If all the collaborating researchers in this research are approved and the research assistant is approved, the data will be provided to the applicant. Comments:
public Navid Kalani
Jahad ave. peimanieh hospital
Jahrom Iran (Islamic Republic of) 7167758256 +98 71 5433 6085 k.navid@juma.ac.ir Jahrom University of Medical Sciences scientific Navid Kalani
Jahad ave. peimanieh hospital
Jahrom Iran (Islamic Republic of) 7167758256 +98 71 5433 6085 k.navid@juma.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Candidates for lumbar disc surgery referred to Peymaniyeh Hospital in Jahrom Complete satisfaction to participate in the study No smoking and alcohol Lack of uncontrolled cardiovascular disease and diabetes and obesity No history of hypertension, no history of asthma and chronic obstructive pulmonary disease Age between 18 and 65 years 18 years 65 years Both occurrence of symptoms indicating an airway problem Risk factor for aspiration Recent airway infection Bmi above 30 M43.06 Spondylolysis, lumbar region Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in group 1 will receive midazolam 20 minutes before extubation at a dose of 20. mg per kg of body weight. Intervention group 2: Patients in group 2 will receive dexmedetomidine 20 minutes before extubation at a dose of 1 mg per kg body weight. Control group: Patients in the control group will receive normal saline 20 minutes before extubation. Vital signs. Timepoint: Before the extubation, 5 minutes after extubation, when entering recovery room, 5 and 10 minutes after recovery. Method of measurement: Monitoring device. Occurrence of cough. Timepoint: During and after extubation. Method of measurement: Likert scale for measuring cough (no cough = 0, mild cough = 1, moderate cough = 2 and severe cough = 3). Nausea and vomiting. Timepoint: During and after extubation. Method of measurement: Likert spectrum for measuring nausea (no nausea = 0, no nausea = 1 and no vomiting = 2). Jahrom University of Medical Sciences Approved 2021-03-03 Ethics committee of jahrom University of Medical Sciences Jahrom, Motahhari Blvd, Jahrom University of Medical Sciences jahrom Fars Iran (Islamic Republic of)