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IRCT20190202042588N1 IRCT 2019-04-28 Shahid Beheshti University of Medical Sciences The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit 2019-05-01 anticipated 40 Complete https://irct.ir/trial/37264 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: -, Randomization description: The present study is a triple-blind study, so that the nurse of the department, the second assistant professor of ICU and the patient are not aware of the type of medication or placebo. To this end, firstly, by the first assistant professor of the ICU determines the patients eligible for inclusion in the study are by random numbers, Blinding description: And the relevant nurse will be given instructions on how to evaluate the sedation in each group. But he does not know the type of medicine. The second Assistant Professor of ICU assesses the patient's severity score, but does not know the type of medication. 3 Dependence on respirator [ventilator] status. Intervention 1: Intervention group: In this group, the fixed dose of Gabapentin (300mg TDS, daily) dissolved in 5cc normal saline is administered through nasogastric tube , and then, if necessary, with the aim of maintaining an Ramsay Score Scale rating of between 2 and 3, fentanyl 0.5 - 2 μg / kg / hr) and midazolam (0.05-0.1 mg / kg) are given intravenously. Intervention 2: Control group: For the control group, the placebo solution which is dissolved in 5 ml of normal saline will be prescribed via NGT, and then, if necessary, with the aim of maintaining the rate of the RSS between 2 to 3, Fentanyl (0.5-2 μg / kg / hr) and Midazolam (0.05-0.1 mg / kg) will be prescribed intravenously. Yes - There is a plan to make this available What will be shared: The whole potential data after being unidentifiable is published When: From 1400 To whom: Medical Society Conditions: Contributing to studies Where to obtain: sarasalarian@sbmu.ac.ir How to obtain: two months Comments:
public Sara Salarian
Shahid Madani Str
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 8001 sarasalarian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Elham Memari
Shahid Madani Str
Tehran Iran (Islamic Republic of) 1617763141 +98 21 73430 drmemary@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1. Age should be ove18 years of age. 2. Mechanical ventilation for more than 3 days 18 years 70 years Both 1. Renal failure. 2. Acute neurological disease and Neuromuscular disease. 3. Unstable Hemodynamic Z99.11 Dependence on respirator [ventilator] status Treatment - Drugs Placebo Intervention group: In this group, the fixed dose of Gabapentin (300mg TDS, daily) dissolved in 5cc normal saline is administered through nasogastric tube , and then, if necessary, with the aim of maintaining an Ramsay Score Scale rating of between 2 and 3, fentanyl 0.5 - 2 μg / kg / hr) and midazolam (0.05-0.1 mg / kg) are given intravenously. Control group: For the control group, the placebo solution which is dissolved in 5 ml of normal saline will be prescribed via NGT, and then, if necessary, with the aim of maintaining the rate of the RSS between 2 to 3, Fentanyl (0.5-2 μg / kg / hr) and Midazolam (0.05-0.1 mg / kg) will be prescribed intravenously Fentanyl consumption. Timepoint: daily. Method of measurement: microgram/kilogram/hour. Midazolam consumption. Timepoint: Daily. Method of measurement: milligram/kilogram. Gabapentin prescribed dosage. Timepoint: Daily. Method of measurement: milligram. Number of days under ventilation. Timepoint: Daily. Method of measurement: Nursing Report. Ramsay scale score. Timepoint: hourly. Method of measurement: Scale Score. Shahid Beheshti University of Medical Sciences Approved 2019-01-06 Ethics committee of ُShahid Beheshti University of Medical Sciences Imam Hossein Hospital, Madani Str, Tehran, Iran. Post Code Tehran Tehran Iran (Islamic Republic of)