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IRCT20190819044559N3 IRCT 2020-06-13 Kerman University of Medical Sciences Stress level after surgery in spinal anesthesia Post traumatic stress and awareness in traumatic lower limb surgery patients after neuraxial anesthesia : A randomized clinical trial 2019-08-29 anticipated 220 Complete https://irct.ir/trial/48545 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients randomly divided in two groups (110 patients in each group) using random allocation sequence with SAS statistical software. according to this method a simple randomization list product and patients`involvement in each group determine base on order entry. we used sequentially numbered, sealed opaque envelopes for allocation concealment. patients (individuals) were the randomization units, Blinding description: Patients, main investigator and data analyser were masked of patients allocation. patients did not know which drug prescribed and checklists did not contain any drug name. only the nurse know the name of medication. 3 Post-traumatic stress. Intervention 1: Intervention group: Propofol infusion of 25-75 micro grams per kilogram per minute is recommended. Intervention 2: Control group: 1-2 mg of midazolam PRN is recommended. 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 Morteza Hashemian
Gharani st. Shahid Bahonar hospital
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3223 5011 mortezahashemian@kmu.ac.ir Kerman University of Medical Sciences scientific Morteza Hashemian
Gharani st. Shahid Bahonar hospital
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3223 5011 mortezahashemian@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Trauma and candidate for lower extremity surgery Age between 18-50 years 18 years 50 years Both History of psychiatric disorders Previous history of lower leg surgery Refusal to attend the study More than 3 hours of surgery duration Severe blood loss Decrease in consciousness and endotracheal intubation during surgery F43.11 Post-traumatic stress disorder, acute Treatment - Drugs Treatment - Drugs Intervention group: Propofol infusion of 25-75 micro grams per kilogram per minute is recommended Control group: 1-2 mg of midazolam PRN is recommended ُُStress level after trauma according to Mississippi questionnaire. Timepoint: One day before surgery, after transfer to Recovery,1 and 7 days after surgery. Method of measurement: Mississippi questionnaire. Awareness level after neuraxial anesthesia with midazolam or propofol. Timepoint: One day before surgery, after transfer to Recovery,1 and 7 days after surgery. Method of measurement: The Brace questionnaire. Kerman University of Medical Sciences Approved 2016-02-13 Ethics committee of Kerman University of Medical Sciences Vice chancellor for research, Kerman University of Medical Sciences, Ebn-e-Sina St.,Jahad Blvd, Kernan,Iran Kerman Kerman Iran (Islamic Republic of)