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IRCT20200825048515N74 IRCT 2024-02-18 Esfahan University of Medical Sciences Effect of intravenous dexmedetomidine and remifentanil on cardiovascular response to extubation Comparative study of the effect of intravenous dexmedetomidine and remifentanil on cardiovascular response to extubation in awake patients undergoing surgery. 2024-03-05 anticipated 90 Complete https://irct.ir/trial/73096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the study, letter A is written on 30 sheets, letter B is written on 30 sheets, and letter C is written on 30 sheets, and each is placed in an envelope. Then, each eligible patient who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the two groups according to the envelope selected without the interference of the researcher, Blinding description: In order to achieve the double-blind study, different doses of remifentanil will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Elective surgery. Intervention 1: The first intervention group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, normal saline 70 cc will be prescribed within 10 minutes and remifentanil 0.3 microgram/kg in a volume of 3 cc one minute after extubation. Intervention 2: The second intervention group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, dexmedetomidine 0.7 μg/kg in 70 ml of normal saline will be prescribed for 10 minutes and normal saline in a volume of 3 cc one minute after extubation. Intervention 3: Control group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, 70 ml of normal saline will be administered within 10 minutes, and then 3 cc of normal saline will be administered one minute after extubation. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hamidreza Shetabi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamid.shetabi@gmail.com Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamid.shetabi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate for elective surgery under general anesthesia Age range from 20 to 60 years American Society of Anesthesiologists (ASA) class equal to 1 or 2 Weight 55 to 85 kg (body mass index 18.5-24.9 kg/m2) Consent to participate in the study 20 years 60 years Both Pregnancy Having underlying diseases (including diabetes, chronic lung disease, cardiovascular disease, uncontrolled blood pressure, kidney failure) Having a heart rate of less than 60 beats/minute or a systolic blood pressure of less than 90 mmHg upon entering the study. Having an allergy to the drugs used Drug use Y83.9 Surgical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Placebo The first intervention group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, normal saline 70 cc will be prescribed within 10 minutes and remifentanil 0.3 microgram/kg in a volume of 3 cc one minute after extubation. The second intervention group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, dexmedetomidine 0.7 μg/kg in 70 ml of normal saline will be prescribed for 10 minutes and normal saline in a volume of 3 cc one minute after extubation. Control group: Induction of anesthesia in patients with propofol (2 mg/kg), fentanyl 2 μg/kg and atracurium (0.5 mg/kg). Then, in this group, 70 ml of normal saline will be administered within 10 minutes, and then 3 cc of normal saline will be administered one minute after extubation. Systolic blood pressure. Timepoint: Before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Monitoring device. Heart rate. Timepoint: Before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Monitoring device. Oxygen saturation (SPO2). Timepoint: Before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Monitoring device. Tachycardia. Timepoint: before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Heart rate more than 100 beats per minute. Bradycardia. Timepoint: before induction of anesthesia, before extubation, 1, 3, 5, and 10 minutes after extubation. Method of measurement: Heart rate less than 60 beats per minute. Cough. Timepoint: After extubation. Method of measurement: Observation. Laryngospasm. Timepoint: After extubation. Method of measurement: Observation. Hypoxia. Timepoint: After extubation. Method of measurement: Oxygen less than 60 bpm. Isfahan University of Medical Sciences Approved 2020-11-23 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)