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

Determining the frequency and severity of postoperative delirium in patients undergoing colorectal surgery who receiving ketamine and melatonin.

Clinical trial with a control group, with parallel groups,double-blind, randomized, phase 3on60 patients.The rand function of Excel software was used for randomization.

This research will be conducted at Imam Khomeini Hospital in Tehran in 1401 and 1402.This study will be conducted as a clinical intervention using drugs and placebo and double blind.Patients will be grouped using random numbers and placed in a sealed envelope.The person responsible for registering the patient's symptoms,the person responsible for statistical analysis,and the operating room nurse do not know about the patient's grouping.

Inclusion : Candidates for elective colorectal cancer surgery The age between 18-70 Patient consent Non-participation of the patient in another drug clinical trial Exclusion: Emergency surgeries Lack of consent Multiple trauma patients Age> 70 Candidate patients for multiple surgeries Chronic renal failure patients (GFR <20% of normal) history of ascites or liver cirrhosis history of anaphylactic medications. heart failure (EF<25%) ischemic heart disease

Patients are randomly divided into 4 equal groups: The first group, 10 mg melatonin the night before the operation and placebo during surgery. The second group received a placebo (oral pill) the night before surgery and bolus dose of 50 mg of ketamine after anesthesia induction. The third group received 10 mg of melatonin the night before surgery and bolus dose of 50 mg of ketamine after anesthesia induction. Fourth group is the control group that receives placebo (oral pill) the night before surgery and placebo (normal saline) after anesthesia induction.

postoperative delirium

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.

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.

Data collected for the primary outcomes will be shared.

access starting after publication

Our data will only be available for people working in academic institutions.

Our data of the study will only be accessible for conducting Meta-analysis.

To access the required data, the researchers can contact Dr. Mostafa Mohammadi: Email address:mohammady_mm@tums.ac.ir

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.