Comparison of the effect of ketamine with propofol on the bispectral index number in patients who are candidates for elective colorectal surgery in 2024 in Imam Khomeini hospital complex

Comparison of the effect of ketamine with propofol on the bispectral index number in patients who are candidates for elective colorectal surgery in 2024 in Imam Khomeini hospital complex

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 128 patients

This study is a double-blind clinical trial (participants and data analysis team). Patients who are candidates for elective colorectal surgery with a minimum duration of two hours referring to the operating room of Mahdi Clinic are randomly divided into two matched intervention and control groups. Monitoring of patients during anesthesia includes routine monitoring and two-dimensional index to check the depth of anesthesia. The changes of the two-dimensional index number are compared between the two groups. After anesthesia, the patients are asked about recalling the events during anesthesia and pain after the operation, and comparison is made between the two groups. Also, postoperative anesthesia complications are also compared between the two groups.

Candidates for elective colorectal surgeries with a minimum duration of two hours referring to the operating room of Mahdi Clinic with ASA 1&2 without exclusion criteria (two spectrums of body mass index, hypertension, psychiatric disorders)

In the intervention group, ketamine is used as an intravenous anesthetic to induce and maintain anesthesia. In the control group, propofol is used as an intravenous anesthetic to induce and maintain anesthesia. Both groups use atracurium during intubation and then as an infusion during the operation for motor relaxation. Fentanyl infusion and morphine sulfate bolus are used in half an hour before the end of the operation in similar amounts.

Bispectral index, recall and complications after anesthesia

In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps the researchers so that the number of samples assigned to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process. The size of all the blocks is equal and we will have 8 blocks of 8 in this two-group experiment (including 4 participants in the intervention group and 4 participants in the control group). Then, in order to randomly select the produced blocks, random number generation software such as R language is used and 8 numbers will be randomly generated from 1 to 8 to select the blocks. For concealment, we use allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the allocated group is not known before the individual is allocated. By using opaque letter envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the letter envelopes in order They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

People participating in the study after informed consent and not having exclusion criteria are randomly placed in one of the control or intervention groups, while they do not know about their group. All procedures and drugs prescribed before induction of anesthesia in the two groups have the same sequence and there is no mention of the type of drug prescribed. After regaining consciousness and transferring to the recovery room, the participants are not given an explanation about the details of the anesthesia method adopted. The data analysis team receives the data in such a way that the name of the group is not known. These people are not specialized in the field of anesthesia, so they cannot find out the group from the difference in the data. They analyze the data in the same way and deliver the results to the researchers.

Data collected by questionnaires without patients' names; including demographic information, data obtained from monitoring methods during anesthesia and data related to the occurrence of complications during and after anesthesia

Starting from one year after the results are published

Researchers working in academic and scientific institutions

In order to be used in scientific research in line with the present trial, if they provide documentation related to their study and the approval of the scientific institutions responsible for the study

Trial's public accountability officer

Submitting the application to the trial's public accountability officer (via SMS or email), referring and reviewing the application by the trial's scientific accountability officer, providing documentation by the public accountability officer after approval