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IRCT20201211049679N1 IRCT 2021-09-22 Shahid Beheshti University of Medical Sciences Effect of Rivastigmine in postoperative delirium after the Radical surgery Effect of Rivastigmine in postoperative delirium after the Radical surgery 2021-09-11 anticipated 60 Complete https://irct.ir/trial/53507 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be entered into the study completely randomly based on random table numbers. Randomization will be done by someone other than the researchers of this project. First, each patient as a member of the community was given a three-digit code (001, 002, 003, ...). Then go to the table, select the starting point and move in the direction of the row or column based on the adjacent three-digit numbers. Select the first three-digit number smaller than the total number of patients as the first sample and ignore numbers greater than the total number of patients. We will continue to do this until we can select 60 items as a sample, Blinding description: We do not inform the participant and researcher about the details of the drugs used (placebo and Rivastigmine). In this study, the doctor who gives the drug to the patient and only with the codes assigned to the drugs (placebo and Rivastigmine), they use them for each patient who will enter the plan and he himself is unaware of how the codes are assigned and the patient himself is the type of drugs (placebo and Rivastigmine). Consumption will be uninformed and only the project instructor will be aware of the drugs (placebo and Rivastigmine) given to patients. N/A Patients undergoing radical surgery. Intervention 1: Rivastigmine (manufactured by Galenus Pharmaceutical Company) will be given to the patient three times a day in doses of 1.5 mg (4.5 mg per day) in the form of infusion before, during and after surgery and every 8 hours. Rivastigmine and placebo (prepared by Abu Reihan Pharmaceutical Company) will be administered through nasogastric tube until the patient is extubated. The given placebo will be similar in color to rivastigmine. The selective dose of rivastigmine was based on previous studies, including the study of Gamberini et al. (20). Rivastigmine is started in the evening of the day before surgery and will continue in the pre- and postoperative periods until the evening of the sixth day after surgery. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily. Intervention 2: The given placebo will be similar in color to rivastigmine. Placebo will also be provided by Abu Reihan Pharmaceutical Company. Which will be randomly assigned to the study group as a control, the researcher will not know which type (drug or placebo) to give to the patient. The placebo is started in the evening of the day before the operation and will continue in the pre- and postoperative periods until the evening of the sixth day after the operation. The exact conditions will be the same as the administration of rivastigmine. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily. Yes - There is a plan to make this available What will be shared: All collected data will be given in writing in the dissertation and articles. When: Summer 1401 To whom: Everyone Conditions: Everyone Where to obtain: Executors and project partners How to obtain: By referring to Shahid Beheshti University of Medical Sciences, the dissertations section can access all the documents. Comments:
public kia kazemzadeh hanani
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
tehran Iran (Islamic Republic of) 1985717443 +98 21 2241 0042 kiiiiiia_kzm@yahoo.com Shahid Beheshti University of Medical Sciences scientific kia kazemzadeh hanani
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
tehran Iran (Islamic Republic of) 1985717443 +98 21 2241 0042 kiiiiia_kzm@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients underwent radical surgery Age over 60 years no limit 60 years Both History of psychiatric disorders Patients in need of emergency surgery Patients with a Mini-Mental State Examination Score (MMSE) of less than 15 Current treatment with cholinesterase inhibitors Using psychiatric drugs Using haloperidol Contraindication for the use of rivastigmine Treatment - Drugs Treatment - Drugs Rivastigmine (manufactured by Galenus Pharmaceutical Company) will be given to the patient three times a day in doses of 1.5 mg (4.5 mg per day) in the form of infusion before, during and after surgery and every 8 hours. Rivastigmine and placebo (prepared by Abu Reihan Pharmaceutical Company) will be administered through nasogastric tube until the patient is extubated. The given placebo will be similar in color to rivastigmine. The selective dose of rivastigmine was based on previous studies, including the study of Gamberini et al. (20). Rivastigmine is started in the evening of the day before surgery and will continue in the pre- and postoperative periods until the evening of the sixth day after surgery. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily. The given placebo will be similar in color to rivastigmine. Placebo will also be provided by Abu Reihan Pharmaceutical Company. Which will be randomly assigned to the study group as a control, the researcher will not know which type (drug or placebo) to give to the patient. The placebo is started in the evening of the day before the operation and will continue in the pre- and postoperative periods until the evening of the sixth day after the operation. The exact conditions will be the same as the administration of rivastigmine. Radical surgery will be performed using standard protocol and standard anesthesia. . Patients are placed in the supine position and angiocatheter 18 is implanted. After hydration of the patient, the appropriate size of the spiral endotracheal tube is selected for the patient. Initially, preoxygenation will be performed on the patient for 3 minutes. To induce anesthesia, a standard protocol including fentanyl at a dose of 1 to 2 micrograms per kilogram of body weight, midazolam at a dose of 3 hundred milligrams per kilogram of body weight, and lidocaine at a dose of 1 to 1.5 milligrams per kilogram of body weight will be used. Patients under general anesthesia with propofol 1-2 mg / kg body weight. They will also receive inhalation using isoflurane during surgery. Postoperative analgesics will include morphine and paracetamol. Also, very low doses of meperidine will be used to relieve tremors after surgery. Doses of sedatives as well as analgesics will be reported daily. Bleeding rate. Timepoint: before and after intervention. Method of measurement: The amount of bleeding during the operation. Postoperative delirium. Timepoint: before and after intervention. Method of measurement: Patient delirium one hour after surgery and at the time of discharge from the intensive care unit. Duration of stay in the ICU. Timepoint: before and after intervention. Method of measurement: Number of days the patient stays in the intensive care unit after surgery. Length of hospital stay. Timepoint: before and after intervention. Method of measurement: Number of days the patient stays in the hospital after surgery. Duration of postoperative consciousness. Timepoint: before and after intervention. Method of measurement: The number of hours the patient regains consciousness after surgery. Postoperative nausea and vomiting. Timepoint: before and after intervention. Method of measurement: The number of times a patient vomits after surgery until discharge from the intensive care unit. Postoperative dizziness. Timepoint: before and after intervention. Method of measurement: Duration of postoperative sensory disturbances and confusion. Train-of-four Fade evaluation. Timepoint: before and after intervention. Method of measurement: Evaluation of peripheral nerve excitability to evaluate neuromuscular block. Extubation time. Timepoint: before and after intervention. Method of measurement: Duration of extubation of the patient after administration of neuromuscular blocking agent. The amount of opiate used. Timepoint: before and after intervention. Method of measurement: The amount of opiate used after surgery. Electrolyte disturbance. Timepoint: before and after intervention. Method of measurement: Having an electrolyte disorder such as hyponatremia. Hemoglobin. Timepoint: before and after intervention. Method of measurement: Serum hemoglobin concentration. Shahid Beheshti University of Medical Sciences Approved 2020-04-21 Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen St ,Shahid Chamran Highway tehran Tehran Iran (Islamic Republic of)