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IRCT20200825048515N62 IRCT 2022-11-06 Esfahan University of Medical Sciences The effect of continuous administration of two doses of sufentanil on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation A comparative study of the effect of two doses of sufentanil continuous infusion on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation. 2022-11-22 anticipated 90 Complete https://irct.ir/trial/66059 interventional Randomization: Randomized, Blinding: Triple 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 three groups according to the envelope selected without the interference of the researcher, Blinding description: In order to achieve the triple-blind study, different doses of sufentanil and placebo 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 Patients requiring tracheal intubation for general anesthesia. Intervention 1: First Intervention group: In this group, anesthesia is induced within 60 seconds using sodium thiopental 5 mg/kg, lidocaine 1.5 mg/kg, atracurium 0.6 mg/kg, and sufentanil with a dose of 0.1 μg/kg. Intervention 2: The second intervention group: in this group, in addition to the drugs of the first group, sufentanil is infused at a dose of 0.2 μg/kg within 60 seconds. Intervention 3: Control group: In this group, in addition to the drugs of the first group, normal saline is prescribed instead of sufentanil. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information"
public Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age range from 18 to 65 years American Society of Anesthesiologists (ASA) I Requires tracheal intubation for general anesthesia Consent to participate in the study 18 years 65 years Both Having heart failure Having a systolic blood pressure of less than 14 mmHg and diastolic blood pressure of 9 mmHg Having respiratory, liver, kidney failure Having airway malformations having an addiction Treatment - Drugs Treatment - Drugs Placebo First Intervention group: In this group, anesthesia is induced within 60 seconds using sodium thiopental 5 mg/kg, lidocaine 1.5 mg/kg, atracurium 0.6 mg/kg, and sufentanil with a dose of 0.1 μg/kg. The second intervention group: in this group, in addition to the drugs of the first group, sufentanil is infused at a dose of 0.2 μg/kg within 60 seconds. Control group: In this group, in addition to the drugs of the first group, normal saline is prescribed instead of sufentanil. Systolic blood pressure. Timepoint: Baseline time, before laryngoscopy, 1, 3, 10 minutes after laryngoscopy. Method of measurement: Ventilation device. Diastolic blood pressure. Timepoint: Baseline time, before laryngoscopy, 1, 3, 10 minutes after laryngoscopy. Method of measurement: Ventilation device. Heart beat. Timepoint: Baseline time, before laryngoscopy, 1, 3, 10 minutes after laryngoscopy. Method of measurement: Ventilation device. Oxygen saturation (SPO2). Timepoint: Baseline time, before laryngoscopy, 1, 3, 10 minutes after laryngoscopy. Method of measurement: Ventilation device. Isfahan University of Medical Sciences Approved 2022-02-20 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)