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IRCT20200825048515N51 IRCT 2022-02-03 Esfahan University of Medical Sciences Comparison of the effect of caffeine and doxapram on respiratory parameters of patients after spinal surgery Comparative study of the effect of caffeine and doxapram on respiratory parameters of patients admitted to intensive care units after spinal surgery 2022-02-04 anticipated 96 Complete https://irct.ir/trial/61606 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 96 eligible patients are randomly selected. For this, the letter A is written on 32 sheets, the letter B is written on 32 sheets, and the letter C is written on 32 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In this study, two drugs, doxapram, caffeine and placebo, are pre-prepared by the pharmacist in the same shape and color and placed in coded packages and delivered daily to the researcher, who is unaware of the type of each. Medications are prescribed. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Spinal surgery. Intervention 1: Intervention group 1: Patients in this group will be infused with doxapram(BehbodDaroo Company) 1 mg / kg for three hours. Intervention 2: Intervention group 2: Patients in this group will be infused with caffeine citrate (Chemidarou Company) 5 mg / kg for three hours. Intervention 3: Control group: Patients in this group will be infused with 250 cc of normal saline as a placebo (Darou Pakhsh Company) for three hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Babak Alikiaii
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alikiaiib@med.mui.ac.ir Esfahan University of Medical Sciences scientific Babak Alikiaii
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alikiaiib@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age category 70-18 years Class I and II classification of the American Society of Anesthesiologists(ASA) Candidate for spine surgery Satisfaction to participate in the study 18 years 70 years Both Existence of confirmed cerebral edema Sensitivity to the studied drugs Having hemoglobin less than 9 g/dL Having a history of underlying diseases (such as cardiovascular disease, lung disease, hypertension, hyperthyroidism) M43.20 Fusion of spine, site unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Patients in this group will be infused with doxapram(BehbodDaroo Company) 1 mg / kg for three hours. Intervention group 2: Patients in this group will be infused with caffeine citrate (Chemidarou Company) 5 mg / kg for three hours. Control group: Patients in this group will be infused with 250 cc of normal saline as a placebo (Darou Pakhsh Company) for three hours. Respiratory Rate. Timepoint: Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention. Method of measurement: Ventilator device. Oxygen saturation(SPO2). Timepoint: Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention. Method of measurement: Ventilator device. Blood pressure. Timepoint: Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention. Method of measurement: Ventilator device. Isfahan University of Medical Sciences Approved 2020-01-09 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)