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IRCT20230603058373N1 IRCT 2023-12-14 Semnan University of Medical Sciences The effect of dexmedetomidine as adjuvant analgesia on postoperative delirium, and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery The effect of dexmedetomidine as adjuvant analgesia on postoperative delirium, and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery 2023-12-12 anticipated 70 Complete https://irct.ir/trial/73394 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: These patients were randomized into two groups using permuted block randomization with 6 blocks (these patients are matched in terms of gender and age ±5 years). , Blinding description: In order to place the research units in two control and intervention groups and to create a random sequence, sealed envelopes were used. In this way, inside half of the envelopes, the letter c meaning the control group and inside the other half, the letter I meaning the intervention group. Then, each of the research units was asked to select an envelope to determine which group they belong to. The participant and the outcome evaluators and dsmb were unaware of the assigned group. 4 Condition 1: post operative delirium. Condition 2: cardiac surgery complications. Intervention 1: Intervention group: In the intervention group, in addition to the common anesthesia protocol, loading dose: 6 mcg/kg/hr intravenous dexmedetomidine with maintenance drip of 0.2 mcg/kg/hour – 1 mcg/kg/hour will be injected. Intervention 2: Control group: common anesthesia protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is after the end of the study
public Mohammad Foroozeshfard
Semnan
Semnan Iran (Islamic Republic of) 99951-35198 31420000-023 mff45@yahoo.com Semnan University of Medical Sciences scientific Mohammad Foroozeshfard
Semnan
Semnan Iran (Islamic Republic of) 99951-35198 31420000-023 mff45@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) history of opium addiction candidate for elective open heart surgery no limit no limit Both weight<50kg history of trauma or neurological lesions liver failure dexmedetomidine allergy EF<30% aortic pump requirement any unpredictable circumstances or pump failure during surgery aortic clamp>2h history of cerebral stroke Impaired level of consciousness history of heart failure kidney failure or history of dialysis F05.8 T82.9 Other delirium Unspecified complication of cardiac and vascular prosthetic device, implant and graft Treatment - Drugs Placebo Intervention group: In the intervention group, in addition to the common anesthesia protocol, loading dose: 6 mcg/kg/hr intravenous dexmedetomidine with maintenance drip of 0.2 mcg/kg/hour – 1 mcg/kg/hour will be injected. Control group: common anesthesia protocol Delirium. Timepoint: daily. Method of measurement: confusion assessment method. Arrhythmia. Timepoint: perioperative and postoperative. Method of measurement: checklist. Postoperative pain. Timepoint: every 4h. Method of measurement: visual analog scale. Cognitive function. Timepoint: preoperative and postoperative. Method of measurement: mini mental state exam. Semnan University of Medical Sciences Approved 2023-03-13 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. semnan Semnan Iran (Islamic Republic of) Approved 2023-03-13 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. semnan Semnan Iran (Islamic Republic of)