]>
IRCT20190215042716N6 IRCT 2023-12-26 Shahid Beheshti University of Medical Sciences A comparative study of the effect of citalopram in the prevention of delirium in intubated patients without brain damage in Labafinejad Hospital ICU A comparative study of the effect of citalopram in the prevention of delirium in intubated patients without brain damage in Labafinejad Hospital ICU 2023-12-03 anticipated 62 Complete https://irct.ir/trial/74125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be included in the study as even or odd numbers. That is, from numbers 1 to 62, all the people with odd numbers will be in the drug group and those with even numbers will be in the placebo group. We will enroll patients into the study sequentially and assign them numbers from 1 to 62 based on order of enrollment. Patients with odd numbers (1, 3, 5, etc.) will be placed in the treatment group. This group will receive 10mg of escitalopram daily via oral administration. Patients with even numbers (2, 4, 6, etc.) will be placed in the placebo group. This group will also receive an oral administration but will not receive the active drug. At the end of the study, we will compare the treatment effect between the two groups. This method allows for random allocation of patients into the two groups. The patients who are in the drug group will be given daily Citalopram 10 mg tablet will be gavage and will be gavage in the placebo group, Blinding description: The nurses will give the drugs of the 2 groups, which are completely matched in terms of shape, color and packaging, to the patients, and after that, the special care nurse, who has no knowledge of the received medicine, will collect the requested parameters of the patients, and then The information in two groups will be given to the data analyst and will be analyzed. 2-3 Condition 1: Delirium. Condition 2: Agitation. Intervention 1: Intervention group: The patients randomly allocated to the intervention group will receive 10mg of escitalopram daily. The escitalopram will be administered orally in the form of a tablet. Patients will take one 10mg tablet of escitalopram by mouth once daily. This group is the active treatment group receiving the study medication escitalopram.Escitalopram is a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder and generalized anxiety disorder. It works by blocking the reabsorption of serotonin in the brain, which increases the level of serotonin available to improve mood and emotional state.The 10mg daily dose of escitalopram was selected as it is a common starting dose for this medication. Patients in the intervention group will come in to the study clinic once a day and be directly observed taking their 10mg dose of escitalopram tablets to ensure adherence. They will then be assessed for efficacy and side effects throughout the trial duration. Intervention 2: Control group: Patients randomly allocated to the control group will receive a placebo. The placebo will be in the form of a tablet similar to the escitalopram tablets but without any active ingredients. Similar to the intervention group, patients in the control group will also receive one oral tablet daily under direct observation. However, since the placebo contains no active drug, they do not actually receive an active treatment. Comparing this group to the intervention group will demonstrate the treatment effect of escitalopram. Yes - There is a plan to make this available What will be shared: The whole potential data after being unidentifiable is published When: One year To whom: Medical Society Conditions: Contributing to studies Where to obtain: Email: n.shafigh@sbmu.ac.ir How to obtain: 2 months Comments:
public Navid Shafigh
No. 15, 26th St., 27th Street, Kurdistan Highway, Tehran Town
Tehran Iran (Islamic Republic of) 1437714791 +98 21 8801 3378 n.shafigh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Navid Shafigh
N0.15, 26 Ave ,27 Ave, Kordestan Blvd , Tehran Town
Tehran Iran (Islamic Republic of) 1437714791 +98 21 8801 3378 n.shafigh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age》18 years old Acute patients hospitalized in the intensive care unit (ICU under mechanical ventilation with a ventilator) Patients hospitalized in the intensive care unit without brain damage Is not currently taking any other antidepressants Not pregnant or lactating Willing to sign an informed consent form 18 years 80 years Both Known hypersensitivity to es-citalopram or any of its components Active suicidal thoughts or behavior Severe liver or kidney failure Uncontrolled arrhythmias Active bleeding History of mania or hypomania Severe personality disorders Current substance abuse or dependence Participation in other clinical trials F05 R45.1 Delirium due to known physiological condition Restlessness and agitation Treatment - Drugs Placebo Intervention group: The patients randomly allocated to the intervention group will receive 10mg of escitalopram daily. The escitalopram will be administered orally in the form of a tablet. Patients will take one 10mg tablet of escitalopram by mouth once daily. This group is the active treatment group receiving the study medication escitalopram.Escitalopram is a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder and generalized anxiety disorder. It works by blocking the reabsorption of serotonin in the brain, which increases the level of serotonin available to improve mood and emotional state.The 10mg daily dose of escitalopram was selected as it is a common starting dose for this medication. Patients in the intervention group will come in to the study clinic once a day and be directly observed taking their 10mg dose of escitalopram tablets to ensure adherence. They will then be assessed for efficacy and side effects throughout the trial duration. Control group: Patients randomly allocated to the control group will receive a placebo. The placebo will be in the form of a tablet similar to the escitalopram tablets but without any active ingredients. Similar to the intervention group, patients in the control group will also receive one oral tablet daily under direct observation. However, since the placebo contains no active drug, they do not actually receive an active treatment. Comparing this group to the intervention group will demonstrate the treatment effect of escitalopram. Agitation. Timepoint: 3 hours after gavage of citalopram and placebo to intubated patients hospitalized in ICU for 14 days. Method of measurement: Richmond agitation sedation scale. Delirium. Timepoint: 3 hours after gavage of citalopram and placebo to intubated patients hospitalized in ICU for 14 days. Method of measurement: CAM_ICU score. Shahid Beheshti University of Medical Sciences Approved 2023-12-03 Ethics committee of Shahid beheshti University od Medical Sciences Faculty of Medicine - Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)