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IRCT20110313006044N2 IRCT 2020-02-15 Bandare-abbas University of Medical Sciences To investigate the effect of dexmedetomidine and fentanyl on spinal analgesia Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section 2020-02-20 anticipated 110 Complete https://irct.ir/trial/41768 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization 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 put in closed envelopes and opened by a person other than the procedure handler, and according to which the drugs were prepared for injection they were given to the procedure physician while the doctor did not know the details of the syringes, 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 given the same drugs and same volume to the 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 Cesarean section. Intervention 1: Intervention group 1: 10mg bupivacaine 0.5% + 5mg dexmedetomedine(PrecedexTM 200mcg/2ml Hospira, Inc,lake Forest, IL60045USA). Intervention 2: Intervention group 2: 10mg bupivacaine 0.5% + 25mg fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany). 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) Candidate for elective cesarean section and gestational age ≥ 37 weeks 16 years 41 years Female Emergency patients Patients with a ban on regional block Patients with heart valve disease Patients with a history of allergy to the drugs used Addictive or alcoholic patients Patients with placenta parvia Patients who require medication during surgery because of incomplete blockage Treatment - Drugs Treatment - Drugs Intervention group 1: 10mg bupivacaine 0.5% + 5mg dexmedetomedine(PrecedexTM 200mcg/2ml Hospira, Inc,lake Forest, IL60045USA) Intervention group 2: 10mg bupivacaine 0.5% + 25mg fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany) Pain rate and duration of analgesia. Timepoint: Measurement of pain and duration of analgesia in recovery and during 6-3 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. . Timepoint: . Method of measurement: . Bandare-abbas University of Medical Sciences Approved 2016-03-14 Ethics Commitee Of Hormozgan University Of Medical Sciences Jomhuri Blvd, Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)