]>
IRCT20211010052718N1 IRCT 2021-11-20 Mazandaran University of Medical Sciences Comparison of the effect of intravenous and oral acetaminophen in the prevention of delirium Comparison of the Effect of intravenous Acetaminophen and oral Acetaminophen in the Prevention of Delirium in the Elderly After Heart Surgery 2020-02-29 anticipated 64 Complete https://irct.ir/trial/59237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment process will be assigned to two groups in blocks. A and B are 16 blocks of 4 and the Random Allocation software is used. The drugs are similar in appearance and volume and are responsible for preparation. The tablets for each group, which are similar in appearance, were prepared in another room and delivered to the person in charge in the operating room. Taber was injected into the patient according to the randomization block and random letters A and B without knowing the type of drug, Blinding description: The injecting nurse and the patient in charge of data collection are kept blind due to the fact that the drugs have a similar appearance and are prepared in another room and delivered to the nurse in sealed envelopes for bilateral blinding of patients into two groups of 32 people. Divided, one hour after admission to the ICU of the first group (A) 1 gram of intravenous acetaminophen and oral placebo to the second group (B) 500 mg of oral acetaminophen and 1 gram of intravenous placebo is administered. They do not have two groups. 3 Prevention of delirium in the elderly after heart surgery. Intervention 1: Intervention group:Intravenous acetaminophen 1 g of Galenus's product is given within one hour after ICU admission and every 8 hours after surgery and continues until the first 48 hours after surgery. Intervention 2: Intervention group:Oral acetaminophen 500 mg of Galenus every 6 hours for 48 hours for a total of 8 postoperative doses. Intervention 3: Control group:Intravenous placebo 1 g of the product of Shahid Ghazi Pharmaceutical Company is given within one hour after hospitalization in the ICU and every 8 hours after the operation and continues until the first 48 hours after the operation. Intervention 4: Control group:Placebo 500 mg of Merck's product is given every 6 hours for 48 hours for a total of 8 doses after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Javad Taziki
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 javadtazikii@gmail.com Mazandaran University of Medical Sciences scientific Javad Taziki
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 javadtazikii@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients who are at least 60 years old and undergo heart surgery 60 years no limit Both Preoperative ventricular ejection fraction less than 30% Emergency method Aortic dissection surgery Pre-existing cognitive dysfunction Parkinson's disease Alzheimer's disease Recent seizures (less than 3 months), taking prophylactic medications for cognitive decline Serum creatinine greater than 2 mg / dL Liver dysfunction (liver enzymes more than four times basal) Alcohol or drug abuse (more than 10 drinks per week) Allergy to any of the studied drugs F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group:Intravenous acetaminophen 1 g of Galenus's product is given within one hour after ICU admission and every 8 hours after surgery and continues until the first 48 hours after surgery. Intervention group:Oral acetaminophen 500 mg of Galenus every 6 hours for 48 hours for a total of 8 postoperative doses Control group:Intravenous placebo 1 g of the product of Shahid Ghazi Pharmaceutical Company is given within one hour after hospitalization in the ICU and every 8 hours after the operation and continues until the first 48 hours after the operation. Control group:Placebo 500 mg of Merck's product is given every 6 hours for 48 hours for a total of 8 doses after surgery. Delrium after surgery. Timepoint: The first 48 hours after surgery continue. Method of measurement: Visual Analogue Scale. The length of stay in the intensive care unit and hospital. Timepoint: After clearance. Method of measurement: Hospital file. Mazandaran University of Medical Sciences Approved 2020-02-19 Ethics Committee of Mazandaran University of Medical Sciences, Imam Khomeini Medical Center Amir Mazandarani Blvd. Imam Khomeini Educational and Medical Center Sari Mazandaran Iran (Islamic Republic of)