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IRCT20151107024909N12 IRCT 2022-10-30 Iran University of Medical Sciences Comparison of dexmedetomidine with propofol in maintaining adequate depth of anesthesia Comparison of dexmedetomidine as a main anastasia drug with propofol on maintain sufficient depth of anesthesia in patients undergoing elective laparotomy 2022-11-06 anticipated 30 Complete https://irct.ir/trial/65952 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Anesthesia. Intervention 1: Intervention group: Induction included midazolam 0.03 mg/kg (Manufacturing factory: Abu Rayhan), fentanyl 2 mg/kg (manufacturer: Norman SA), propofol 1-2 mg/kg (manufacturer: Bran B), cis-atracurium 0.2 mg/kg. kg (Manufacturing factory: Behin Tamin Roza Mod Co.) After reaching the necessary conditions for intubation, the patient is intubated with a suitable size tube. During this time, the dexmedetomidine infusion continues. In order to administer anesthesia during the procedure, the infusion of dexmedetomidine (manufacturer: Exir) continues at a rate of 1 mcg/kg/hr, and the patient receives 5 mg of morphine intravenously, and the infusion of cis-atracurium is started at the rate of 2 mcg/kg/min. If the depth of anesthesia increases more than 50, the amount of dexmedetocidin 0.25% is added and it can be added up to ten times the initial sedation dose to maintain the level of sedation at 40-50. If the depth of anesthesia decreases from 40 in this group, the dose of dexmedetomidine will be reduced until the depth of anesthesia reaches an acceptable level, and if there is no response to increasing the dose of propofol or complications, isoflurane gas (manufacturer: Piramal) will be used in the amount of 0.5%. As long as the depth of anesthesia can be maintained as necessary, the concentration of inhalation gas is increased. Intervention 2: Control group: Induction included midazolam 0.03 mg/kg (Manufacturing factory: Abu Rayhan), fentanyl 2 mg/kg (manufacturer: Norman SA), propofol 1-2 mg/kg (manufacturer: Bran B), cis-atracurium 0.2 mg/kg. kg (Manufacturing factory: Behin Tamin Roza Mod Co.) After reaching the necessary conditions for intubation, the patient is intubated with a suitable size tube. Normal saline infusion continues during this time. To administer anesthesia during the procedure, propofol infusion is started at a dose of 50-100 mcg/kg/min (Manufacturing factory: Shafa Farmed). Patients receive 5 mg of intravenous morphine and the infusion of Cis-atracurium starts with a dose of 2 mcg/kg/min. To keep the depth of anesthesia constant between 40-50, if the depth of anesthesia increases by 20%, the infusion of propofol will be increased. And if the depth of anesthesia falls below 40, the amount of propofol will be reduced by 20% and this will continue until the depth of anesthesia can be kept between 40 and 50 and the maximum dose of propofol (200 ug/kg) reached, and in case of failure to respond to propofol dose increase or side effects, 0.5% isoflurane gas (manufacturer: Piramal) will be used until the depth of anesthesia can be maintained at the required level, the inhalation gas concentration will be increased. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the work and consulting with all the writers and executive agents, I will be decided.
public Faranak Rokhtabnak
Firouzgar hospital. Vali Asr Sq. Beh Afarin Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 6640 6761 rolhtabnak.f@iums.ac.ir Iran University of Medical Sciences scientific Faranak Rokhtabnak
Firouzgar hospital. Vali Asr Sq. Beh Afarin Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 6640 6761 rolhtabnak.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 20 years Patients who are candidates for laparotomy surgery Surgery with a time of more than 3 hours under general anesthesia 20 years 60 years Both 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 Y48.4 Anaesthetic, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Induction included midazolam 0.03 mg/kg (Manufacturing factory: Abu Rayhan), fentanyl 2 mg/kg (manufacturer: Norman SA), propofol 1-2 mg/kg (manufacturer: Bran B), cis-atracurium 0.2 mg/kg. kg (Manufacturing factory: Behin Tamin Roza Mod Co.) After reaching the necessary conditions for intubation, the patient is intubated with a suitable size tube. During this time, the dexmedetomidine infusion continues. In order to administer anesthesia during the procedure, the infusion of dexmedetomidine (manufacturer: Exir) continues at a rate of 1 mcg/kg/hr, and the patient receives 5 mg of morphine intravenously, and the infusion of cis-atracurium is started at the rate of 2 mcg/kg/min. If the depth of anesthesia increases more than 50, the amount of dexmedetocidin 0.25% is added and it can be added up to ten times the initial sedation dose to maintain the level of sedation at 40-50. If the depth of anesthesia decreases from 40 in this group, the dose of dexmedetomidine will be reduced until the depth of anesthesia reaches an acceptable level, and if there is no response to increasing the dose of propofol or complications, isoflurane gas (manufacturer: Piramal) will be used in the amount of 0.5%. As long as the depth of anesthesia can be maintained as necessary, the concentration of inhalation gas is increased. Control group: Induction included midazolam 0.03 mg/kg (Manufacturing factory: Abu Rayhan), fentanyl 2 mg/kg (manufacturer: Norman SA), propofol 1-2 mg/kg (manufacturer: Bran B), cis-atracurium 0.2 mg/kg. kg (Manufacturing factory: Behin Tamin Roza Mod Co.) After reaching the necessary conditions for intubation, the patient is intubated with a suitable size tube. Normal saline infusion continues during this time. To administer anesthesia during the procedure, propofol infusion is started at a dose of 50-100 mcg/kg/min (Manufacturing factory: Shafa Farmed). Patients receive 5 mg of intravenous morphine and the infusion of Cis-atracurium starts with a dose of 2 mcg/kg/min. To keep the depth of anesthesia constant between 40-50, if the depth of anesthesia increases by 20%, the infusion of propofol will be increased. And if the depth of anesthesia falls below 40, the amount of propofol will be reduced by 20% and this will continue until the depth of anesthesia can be kept between 40 and 50 and the maximum dose of propofol (200 ug/kg) reached, and in case of failure to respond to propofol dose increase or side effects, 0.5% isoflurane gas (manufacturer: Piramal) will be used until the depth of anesthesia can be maintained at the required level, the inhalation gas concentration will be increased. Depth of anesthesia. Timepoint: At the beginning and during surgery. Method of measurement: Anesthesia depth monitoring device. Pain level of patients. Timepoint: From the beginning of recovery every 15 minutes up to three times. Method of measurement: Visual analog scale. Agitation score. Timepoint: From the beginning of recovery every 15 minutes up to three times. Method of measurement: Based on the information in the patient's file. Sedition score. Timepoint: From the beginning of recovery every 15 minutes up to three times. Method of measurement: Based on the information in the patient's file. Iran University of Medical Sciences Approved 2022-04-23 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)