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IRCT20110402006115N4 IRCT 2018-12-31 Esfahan University of Medical Sciences Effect of Dexmedetomidine- Fentanil on postoperative pain of spine surgery Dexmedetomidine- Fentanil on postoperative pain management The effect of adding Dexmedetomidine to fentanyl for pain management after spinal fusion surgery using intravenous patient controlled analgesia pumps 2018-03-21 anticipated 66 Complete https://irct.ir/trial/32564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the individuals referred for spinal surgery who have criteria for entering the study were identified and placed randomly into two groups, Blinding description: The pumps are provided by an anesthetist technician according to the patient's specifications and are available to the researcher. The investigator is unaware of the content inside the pump. 3 spinal surgery. Intervention 1: Intervention group: dexmedetomidine 0.5 mcg/kg + fentanyl 0.5 mcg/kg in PCA infusion pump for 24 hours after surgery. The required amount is calculated separately for each patient. Intervention 2: Control group: saline normal 0.9 % + fentanyl 0.5 mcg/kg in PCA infusion pump for 24 hours after surgery. The required amount is calculated separately for each patient. No - There is not a plan to make this available Justification or reason for not sharing IPD is Dissatisfaction with the participants in the study
public Dr Mojtaba Rahimi
Kashani street , kashani hospital
Isfahan Iran (Islamic Republic of) 8143764471 +98 31 3235 0004 rahimi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Mojtaba Rahimi
Kashani street, kashani hospital
Isfahan Iran (Islamic Republic of) 8143764471 +98 31 3235 0004 rahimi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The candidate for the posterior fusion of the lower back and the thoracic spine Age range 20 to 70 years Patients ASA 1 or 2 Satisfaction to participate in the study Educable and have the ability to cooperate 20 years 70 years Both History of acute allergic reaction to Dexmedetomidine or Fentanil Patients with mental and physical disabilities in the application of pain pumps The presence of any moderate to severe CVD and respiratory instability Treatment - Drugs Placebo Intervention group: dexmedetomidine 0.5 mcg/kg + fentanyl 0.5 mcg/kg in PCA infusion pump for 24 hours after surgery. The required amount is calculated separately for each patient. Control group: saline normal 0.9 % + fentanyl 0.5 mcg/kg in PCA infusion pump for 24 hours after surgery. The required amount is calculated separately for each patient. Pain score base on VAS criteria. Timepoint: Start logging in to recovery, every hour to 24 hours. Method of measurement: VAS CRITERIA SCORE. Esfahan University of Medical Sciences Approved 2017-10-18 Ethics committee of Isfahan University of Medical Sciences hezar jerib ave. Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)