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IRCT20190225042836N1 IRCT 2019-04-16 Gonabad University of Medical Sciences The Effect of using Pneumatic Pump on the Hypotension due to sedation in Patients Admitted to the ICU The effect of pneumatic pumps on hypotension due to Midazolam and Fentanyl in patients admitted to the ICU 2019-03-06 anticipated 56 Complete https://irct.ir/trial/37830 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: From the research community who has the inclusion criteria, participants will be selected randomly and they will be divided into treatment and control groups using permuted block technique (4 patients in each block), Blinding description: Non-invasive blood pressure will be measured by someone except the researcher. N/A Unspecified disorders of the circulatory system. Intervention 1: Intervention group: In supine mode, on patients that are hospitalized in ICU and receive "Midazolam" and "Fentanyl" according to the specialist's order, Pneumatic pump will be applied in 3 phases and under 35-45 mmHg pressure, each phase 1 minute (45 seconds under pressure and 15 seconds of discharge). Intervention 2: Control group: There will be no treatment in this group by the researcher. Yes - There is a plan to make this available What will be shared: A part of data When: 6 months after publishing results To whom: Academic and Scientific researchers Conditions: Observation of ethical principles from documentations Where to obtain: bagherzadeh.a.stu@gmu.ac.ir - 00989159361026 - 00985157221488 How to obtain: Phone call 0098 915 9361026 Comments:
public Amir Bagherzadeh Bahabadi
No. 2, Danesh Ave.
Gonabad Iran (Islamic Republic of) 9691174333 +98 51 5722 4058 bagherzadeh.a.stu@gmu.ac.ir Gonabad University of Medical Sciences scientific Amir Bagherzadeh Bahabadi
No. 2, Danesh Ave.
Gonabad Iran (Islamic Republic of) 9691174333 +98 51 5722 4058 bagherzadeh.a.stu@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Hospitalized in ICU under mechanical ventilation Written consent form from patient's relatives (first degree relative) Having order to receive 0.01-0.05 mg/kg "Midazolam" and 5 µg/kg "Fentanyl" 20 percent decrease in non-invasive blood pressure (MAP-SBP) to the initial non-invasive blood pressure No ulcers, skin or vascular effects or fractures in the legs Stable hemodynamics according to the ICU specialists No Cardiovascular failure according to the patients medical history Patients should be 20-80 years old 20 years 80 years Both Making an unstable status while doing treatment Contraindications for "Midazolam" or "Fentanyl" or both of them I95.2 Hypotension due to drugs Treatment - Other Treatment - Other Intervention group: In supine mode, on patients that are hospitalized in ICU and receive "Midazolam" and "Fentanyl" according to the specialist's order, Pneumatic pump will be applied in 3 phases and under 35-45 mmHg pressure, each phase 1 minute (45 seconds under pressure and 15 seconds of discharge) Control group: There will be no treatment in this group by the researcher Non-invasive blood pressure variations. Timepoint: Measuring non-invasive blood pressure before, instantly, 3 and 5 minutes after treatments. Method of measurement: Monitoring device. Heart beat variation. Timepoint: Measuring heart beat before, instantly, 3 and 5 minutes after treatments. Method of measurement: Monitoring device. Gonabad University of Medical Sciences Approved 2019-02-20 Ethics committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Mahdizadeh Blvd. Gonabad Razavi Khorasan Iran (Islamic Republic of)