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IRCT20110313006044N4 IRCT 2020-09-24 Bandare-abbas University of Medical Sciences Evaluation of adding intrathecal fentanyl and dexmedetomidine on postoperative analgesia Comparison of the analgesic effect of intrathecal dexmedetomidine versus fentanyl in opioid dependence undergoing lower limb orthopedic surgery 2020-09-30 anticipated 75 Complete https://irct.ir/trial/51124 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation was performed based on Random allocation software and based on that even numbers were considered for dexmedetomidine and odd numbers were considered for fentanyl accordingly. The numbers were placed in sealed envelopes and returned by someone other than the procedure performer. Anesthesia was performed by an anesthesiologist and anesthesia resident in charge of data collection and the patients both did not know about the injectable drug and how it was randomized, Blinding description: In order to eliminate bias from patient's awareness or anesthesia assistant and person who evaluate the results and its possible impact on the outcome of the study, the study will be conducted in a double-blind condition. After receiving written informed consent from patients, spinal anesthesia was done by anesthesiologist, then relevant information was recorded in the questionnaire by the anesthesiologist who was not aware of the injection of the drugs. It is obvious that the patient and the anesthesiologist were not aware of the type of drug being administered. 3 Lower limb sugary. Intervention 1: First Intervention group: 12.5 mg bupivacaine 0.5% hyperbaric with 5 micrograms dexmedetomidine via intrathecal injection. Intervention 2: Second Intervention group: 12.5 mg bupivacaine 0.5% hyperbaric with 25 micrograms fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany) via intrathecal injection. Intervention 3: Control group: 12.5 mg bupivacaine and 0.5 cc Normal saline via intrathecal injection. Yes - There is a plan to make this available What will be shared: All data can be shared When: Starting the post-access period of the paper was accepted To whom: All researchers Conditions: All researchers Where to obtain: Correspondence Dr Hashim Jarineshin contact by email hjarineshin@yahoo.com How to obtain: Details are available within a week at most Comments:
public Hashem Jarineshin
Jomhuri Blvd, Shahid Mohammadi Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 Hjarineshin@yahoo.com Bandare-abbas University of Medical Sciences scientific Hashem Jarineshin
Jomhuri Blvd, Shahid Mohammadi Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 Hjarineshin@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Addict patients with aged 18-65 years andASA II, I Candidate for lower limb orthopedic surgery under spinal anesthesia 18 years 65 years Both Emergency surgeries Patients with severe valvular heart disease Patients with psychological disorders Patients with a history of seizures Patients with ASA > II Patients with a history of allergy tothe drugs used Patients with a ban on spinal anesthesia (coagulation problems, high ICP, sepsis, infection at the injection site) Patients with neurological defects Patients who fail the block and need to induce general anesthesia S82.9 Unspecified fracture of lower leg Treatment - Drugs Treatment - Drugs Treatment - Drugs First Intervention group: 12.5 mg bupivacaine 0.5% hyperbaric with 5 micrograms dexmedetomidine via intrathecal injection Second Intervention group: 12.5 mg bupivacaine 0.5% hyperbaric with 25 micrograms fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany) via intrathecal injection Control group: 12.5 mg bupivacaine and 0.5 cc Normal saline via intrathecal injection Postoperative analgesia. Timepoint: Patients' pain intensity is measured and recorded based on visual analog scale (VAS) in recovery during 2,4,6,12 hours after surgery. Method of measurement: Patients' severity of pain is based on the Visual Analogues Scale, with the left side indicating no pain and the right side showing the number "10" indicating the most severe pain. Score style 1-3 indicates mild pain, 4-7 moderate pain, severe pain 8-10), duration of analgesia from time to block until patient requests for analgesics. Side effects after surgery including nausea and vomiting and. Timepoint: During surgery and in recovery between 2,4,6,12 hours after surgery is measured and recorded. Method of measurement: Patient dissatisfaction. Bandare-abbas University of Medical Sciences Approved 2019-10-13 Ethics Commitee Of Hormozgan University Of Medical Sciences Jomhuri Blvd, Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)