Comparison of dexmedetomidine as a main anastasia drug with propofol on maintain sufficient depth of anesthesia in patients undergoing elective laparotomy

Comparison of dexmedetomidine as a main anastasia drug with propofol on maintain sufficient depth of anesthesia in patients undergoing elective laparotomy

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 30 patients. In order to randomize, the block randomization method will be used.

In this research, all patients who need elective laparotomy surgery, referring to Firuzgar Hospital, will be included in the study. Patients will be randomly divided into 2 groups based on blocks of 6. The sample size for each study group is 15 people. A total of 30 patients will be examined. Patients, surgeon and data analyst will be blinded.

Inclusion criteria: Patients who are candidates for elective laparotomy surgery; patients over 18 years. Exclusion criteria: Patients over 60 years; Emergency surgery; Contraindications to the use of dexmedetomidine; Pregnancy or breastfeeding; Drug addiction; Uncontrolled blood pressure; Body mass index above 30.

Intervention group: In order to administer anesthesia during the procedure, dexmedetomidine infusion continues at a rate of 1 mcg/kg/hour, and the patient receives morphine 5 mg intravenously, and cis-atracurium infusion is started at a rate of 2 mcg/kg/minute. Control group: Propofol infusion is started at a dose of 50-100 mcg/kg/minute to administer anesthesia during the procedure. Patients receive 5 mg of intravenous morphine and the infusion of cis-atracurium is started at a dose of 2 mcg/kg/min.

Depth of anesthesia; Pain level of patients; Agitation score; Sedation score

Patients will be randomly divided into two groups. The randomization tool will be a random sequence generation software called SAS. In addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 6 blocks will be formed and in each block, 3 people from intervention group and 3 people in control group 3 will be placed. A total of 5 blocks will be considered to reach the sample size. The blocks contain numbers, odd numbers represent the intervention group and even numbers represent the control group. Their order will be determined by the software initially. Random allocation concealment will be done using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. the door At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

The surgeon and the patients will be blinded and unaware of the type of anesthesia. Similar serums were used for concealment, without drug name labels and only with a code. Patients will be aware that they will be randomly assigned to one of the two treatment groups but will not know which treatment will be provided in that group. The surgeon also knows that two different methods will anesthetize the patients, but he will not know which method will be used for each patient. The person in charge of data collection, the analyst, and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind.