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IRCT2015112525235N1 IRCT 2016-11-04 Vice Chancellor for Reseach of Shahid Beheshti University of Medical Science Comparison of anesthetic drugs to create deep sedation. Compare the effects of low-dose combination of anesthetic drugs (including fentanyl, propofol, midazolam, ketamine and lidocaine) with the usual dose of propofol in creating deep sedation 2015-03-21 anticipated 122 Complete https://irct.ir/trial/21130 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were divided by blocked randomization method. 2 Procedural Sedation and Analgesia. Intervention 1: Intervention group: Intervention group patients are given low doses of sedative drugs, including propofol in a dose of 0.5 mg per kilogram of body weight, ketamine 0.2 to 0.25 mg per kilogram of body weight, midazolam at doses of 0.01 to 0.02 mg per kilogram of body weight, fentanyl 0.5 to 1 microgram per kg of body weight and lidocaine 0.5 to 1 mg per kilogram of body weight Intravenously . Intervention 2: Control group: patients in control group are given propofol at a dose of 1 mg per kilogram and fentanyl 1 microgram per kilogram of body weight Intravenously .

public Shahram Shokrzadeh.MD

Emam Hossein Hospital, Shahid Madani Ave, Tehran

Tehran Iran (Islamic Republic of) - +98 21 73430 shahram.shokrzadeh@gmail.com Shahid Beheshti University of Medical Science scientific Afshin Amini . MD

Emam Hossein Hospital, Shahid Madani Ave, Tehran, Iran

Tehran Iran (Islamic Republic of) - +98 21 73430 a.amini@sbmu.ac.ir Shahid Beheshti University of Medical science Iran (Islamic Republic of) Inclusion criteria: Patients admitted to the emergency department of Emam Hossein hospital over 15 years to 60 years of age and they need Procedural sedation and analgesia (PSA) Exclusion criteria: previous allergy to drugs used in the study; sensitivity to egg or soy products; Hemodynamic Instability; pregnancy; drug interactions; increased intracranial pressure (ICP) 15 years 60 years Both Treatment - Drugs Treatment - Drugs Intervention group: Intervention group patients are given low doses of sedative drugs, including propofol in a dose of 0.5 mg per kilogram of body weight, ketamine 0.2 to 0.25 mg per kilogram of body weight, midazolam at doses of 0.01 to 0.02 mg per kilogram of body weight, fentanyl 0.5 to 1 microgram per kg of body weight and lidocaine 0.5 to 1 mg per kilogram of body weight Intravenously . Control group: patients in control group are given propofol at a dose of 1 mg per kilogram and fentanyl 1 microgram per kilogram of body weight Intravenously . The needed time for recovery from deep sedation. Timepoint: Every 30 seconds since the beginning of deep sedation. Method of measurement: The interval time between induction of sedation (Ramsay score 6) and recovery (Ramsy score of 2. The depth of sedation. Timepoint: Every 30 seconds since the beginning of sedation. Method of measurement: the depth of sedation according to the Ramsay score. The time required to create deep sedation. Timepoint: Every 30 seconds. Method of measurement: Since the beginning of sedative drugs to achieve deep sedation (Ramsay score equal to 6). Cardiac arrhythmia. Timepoint: continuously since the beginning of sedation. Method of measurement: Cardiac monitoring. Arterial blood pressure. Timepoint: Before prescription of drugs, then every 5 minutes until recovery time. Method of measurement: Using the sphygmomanometer. Physician and patient's satisfaction. Timepoint: after the procedure. Method of measurement: By questionnaire. Arterial blood oxygen saturation. Timepoint: Continuously since the beginning of sedation. Method of measurement: Pulse oximetry. Vomiting. Timepoint: since the beginning of sedation until full recovery. Method of measurement: Observation. - - Vice Chancellor for Reseach of Shahid Beheshti University of Medical Science Approved 2015-02-15 Ethic Commitee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Science, Next to the Ayatollah Taleghani Hospital, Martyr Arabi Street, Yemen Street, Martyr Chamran highway, Tehran Tehran Iran (Islamic Republic of)