Postoperative delirium in patients with colorectal cancer
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ABSTRACT: 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.
Primary outcome(s): Postoperative delirium. Timepoint: 12 and 24 hours after surgery. Method of measurement: Confusion Assessment Method-Intensive Care Unit.
Study Design: 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
DISEASE(S): Colon Cancer,Malignant Neoplasm Of Colon
PROVIDER: 23604 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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