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IRCT20210405050848N2 IRCT 2021-06-13 Shahid Beheshti University of Medical Sciences Adjusting opioide use Evaluation of the effect of gabapentin against clonidine in reducing the dose of sedation in patients with mechanical artificial ventilation 2021-07-23 anticipated 90 Complete https://irct.ir/trial/56722 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the entry of participants according to the inclusion criteria, the pre-test will be performed using a cryptographic evaluation checklist, then randomly assigned by the head nurse based on blocking. Given that 90 people must be included in the study and there will be three groups (gabapentin, clonidine and control), taking into account all possible possibilities, the number of blocks will be calculated (it is necessary to explain that the number of blocks of the compound formula : C (n, r) = C_r ^ n = n C r = (n¦r) will be obtained), Blinding description: The study is double-blind. The medicine is prescribed by a doctor and injected by a nurse and recorded in a checklist. The patient and the researcher have no role in randomly assigning the samples to the intervention or control group, and the intervention will be performed and the results will be recorded by the relevant nurse. The samples will be analyzed by a doctor. The interpretation of the data will be done by the researcher and will be decided based on the interpreted results. 3 Adjust opioid use. Intervention 1: Intervention group: Gabapentin 300 mg tablets are gavaged three times a day. Fentanyl ampoules are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. Intervention 2: Intervention group: Clonidine 0.1 mg of clonidine tablets four times a day. Fentanyl ampoules are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. Intervention 3: Control group: The ampole of midazolam is injected at 20 to 100 microbes per kilogram. Fentanyl ampoles are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Jafar Vakili
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 jafar.vakili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Jafar Vakili
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 jafar.vakili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Patients connected to a mechanical ventilator 18 years no limit Both History of Clonidine allergy History of Gabapentine allergy Opioid ove Opioid overdose Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Gabapentin 300 mg tablets are gavaged three times a day. Fentanyl ampoules are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. Intervention group: Clonidine 0.1 mg of clonidine tablets four times a day. Fentanyl ampoules are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. Control group: The ampole of midazolam is injected at 20 to 100 microbes per kilogram. Fentanyl ampoles are also given as a PRN at 25 to 200 micro / hour infusion. We record the need for fentanyl to achieve sedation in the range of 3 to 4 groups and finally compare. Sedation of patients connected to a mechanical ventilator. Timepoint: Before and after medication. Method of measurement: Ramsay score. Adjustment Opioide use. Timepoint: Before and after medication. Method of measurement: Ramsay score. Shahid Beheshti University of Medical Sciences Approved 2021-05-11 Ethics committee of Shahid beheshti University of Medical Sciences th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)