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IRCT20120430009593N15 IRCT 2021-12-01 Shahid Beheshti University of Medical Sciences Effect of intravenous Dexmedetomidine and Dexamethasone on spinal anesthesia in opium addicted patients Comparison between intravenous Dexamethasone and Dexmedtomidine on spinal anesthesia level in opium addicted patients 2021-12-21 anticipated 27 Complete https://irct.ir/trial/59785 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method : Randomization : Simple Randomization Unit: based on patient Randomization Tool: Random Number Table - Block stratified randomization software window version 6.0. Using this software, a random number table will be created and accordingly , the sample will be divided into two groups of 30 patients in such a way that at the beginning of each person's entry, his / her number will be matched with the table so the type of group, dexmedetomidine or dexamethasone , will be specified. The participants will not aware of the allocation of groups and won't know that the study will have two groups. The drugs will be given by first anesthesiologist who knows the groups. The person who will assess the outcome (the second anesthesiologist ) also won't be aware of the group , Blinding description: The person performing the spinal anesthesia, is the same person who will evaluate the spinal levels and does not know about the group .The patients also does not know the type of group. Another anesthesiologist who knows the type of drugs and the group will give the drugs. 3 Dexmedetomidine and Dexamethasone on Spinal Anesthesia Level in Opium Addicted Patients. Intervention 1: Control group : Dexamethasone 8 mg 10 minutes before spinal anesthesia with bupivacaine and then normal saline infusion at a rate of 0.5 μg / kg / hr during surgery. Each Dexamesthasone ampule consists of 8 mg and belongs to Alborz Drug Company. Intervention 2: Intervention group : Dexmedetomidine infusion at a dose of 0.5 micrograms per kilogram of body weight for 10 minutes before spinal anesthesia and then infusion at a dose of 0.5 micrograms per kilogram of body weight.Each Dexmedtomidine vial consists of 2 c.c (200microgram )and belongs to Exir Drug company. Yes - There is a plan to make this available What will be shared: Information about the main and secondary outcome without the names of the people When: Start the access period immediately after printing the results To whom: Only for researchers working in academic and scientific institutions Conditions: request data via email Where to obtain: Send email to the scientific director of research How to obtain: After sending an email to the scientific director of the research and stating the reason for the request, the documents will be sent within 3 months Comments:
public Elham Memary
operating room, ground floor,Imam Hossein Hospital, Shahid Madani St.,Imam Hossein Square
Tehran Iran (Islamic Republic of) 1617763141 00982173430 drmemary@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Elham Memary
operating room, ground floor,Imam Hossein Hospital, Shahid Madani St.,Imam Hossein Square
Tehran Iran (Islamic Republic of) 1617763141 00982173430 drmemary@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with drug addiction Patients with ASA class 1,2 Patients with BMI <30 Patients aged 18 to 65 years 18 years 65 years Both Pregnant patients Patients with dissatisfaction with spinal anesthesia Patients with coagulation disorders Patients with a history of multiple sclerosis Patients with local infection in the lumbar region Patients with allergies to local anesthetics Patients with systemic infections Patients with diabetic neuropathy Patients with bradycardia with less than 50 HR Treatment - Drugs Treatment - Drugs Control group : Dexamethasone 8 mg 10 minutes before spinal anesthesia with bupivacaine and then normal saline infusion at a rate of 0.5 μg / kg / hr during surgery. Each Dexamesthasone ampule consists of 8 mg and belongs to Alborz Drug Company Intervention group : Dexmedetomidine infusion at a dose of 0.5 micrograms per kilogram of body weight for 10 minutes before spinal anesthesia and then infusion at a dose of 0.5 micrograms per kilogram of body weight.Each Dexmedtomidine vial consists of 2 c.c (200microgram )and belongs to Exir Drug company Onset of Sensory Block. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours. Method of measurement: Pinprick Test. Onset of Motor Block. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours. Method of measurement: Bromage Scale. Duration of Motor Block. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Every to 2 Hours. Method of measurement: Bromage Scale. Regression of Two Level of Sensory Block. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 hours. Method of measurement: Pinprick Test. Total Analgesia Time. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours. Method of measurement: ََAccording to Time with Visual Analogue Scale less than 3. The First Time for Analgesia Requirement. Timepoint: Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours. Method of measurement: Analgesic Request According to VAS More than 3. Shahid Beheshti University of Medical Sciences Approved 2021-07-13 Ethics committee of ShahidBeheshti University of Medical Sciences Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)