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IRCT20120527009886N2 IRCT 2023-03-07 Tehran University of Medical Sciences postoperative delirium in patients with colorectal cancer Investigating the incidence of postoperative delirium in patients with colorectal cancer undergoing elective surgery after intervention with ketamine and/or melatonin compared to the control group 2023-03-08 anticipated 60 Complete https://irct.ir/trial/68762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization lists are computer-based by a statistician and the participants and project managers will be completely unaware (blind) about the intervention and control groups. Placebo and melatonin pills are identical. Placebo pills are produced by Faculty of Pharmacy, Tehran University of medical science. The concealment of supplements will be done by a third person, and the participants and investigators are not aware of the groups’ assignments until the end of analysis, Blinding description: The pills are inside a sealed envelope with a specific code. Syringes containing ketamine or normal saline (as placebo) are stored in the operating room refrigerator and coded.Both the researcher and the nurse are unaware of the relationship between the code and the capsule type (melatonin or placebo/ketamine or placebo). Only the main researcher and the physician responsible for the patient's anesthesia (who are not involved in sampling or recording the patients' information) are aware of the codes and contents of the drug or syringe envelope. 3 Colon cancer. Intervention 1: Control group: They will receives a placebo (oral pill) the night before the operation and a placebo (normal saline solution) after induction of anesthesia. Intervention 2: Intervention group 1: The night before the operation, 10 mg of melatonin and placebo during the operation. Intervention 3: Intervention group 2: The night before the operation, they receive a placebo (oral pill) and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia. Intervention 4: Intervention group 3: The night before the operation, they receive 10 mg of melatonin and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: access starting after publication To whom: Our data will only be available for people working in academic institutions. Conditions: Our data of the study will only be accessible for conducting Meta-analysis. Where to obtain: To access the required data, the researchers can contact Dr. Mostafa Mohammadi: Email address:mohammady_mm@tums.ac.ir How to obtain: The applicants should provide a description of the propose of their Meta-analysis. That request will be assessed, and if we agree to the request, the data will be emailed. Comments:
public Mostafa Mohammadi
Keshavarz Blvd., Dr. Gharib St
Tehran Iran (Islamic Republic of) 1416634793 0098.21.61190 mohammady_mm@tums.ac.ir Tehran University of Medical Sciences scientific Mostafa Mohammadi
Keshavarz Blvd., Dr. Gharib St
Tehran Iran (Islamic Republic of) 1416634793 0098.21.61190 mohammady_mm@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Candidates for elective colorectal cancer surgery Patient age between 18 and 70 years Patient consent to participate in the plan Non-participation of the patient in another drug clinical trial 18 years 70 years Both Emergency surgeries Non-consent Multiple trauma cases Age more than 70 years Candidate patients for multiple surgeries (or second or third surgery cases) Chronic renal failure patients (or single kidney patients or patients with GFR less than 20% of normal) Patients with a history of ascites or liver cirrhosis Patients with a history of anaphylactic reactions to melatonin, ketamine, or propofol Patients with heart failure (cardiac ejection fraction less than 25%) Patients with ischemic heart disease C18 Malignant neoplasm of colon Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: They will receives a placebo (oral pill) the night before the operation and a placebo (normal saline solution) after induction of anesthesia. Intervention group 1: The night before the operation, 10 mg of melatonin and placebo during the operation. Intervention group 2: The night before the operation, they receive a placebo (oral pill) and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia. Intervention group 3: The night before the operation, they receive 10 mg of melatonin and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia. Postoperative delirium. Timepoint: 12 and 24 hours after surgery. Method of measurement: Confusion Assessment Method-Intensive Care Unit. Tehran University of Medical Sciences Approved 2022-02-14 Ethics Committee of Tehran University of Medical Sciences Keshavarz Boulevard, Porsina Street, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)