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IRCT20101211005362N24 IRCT 2020-06-06 Esfahan University of Medical Sciences effect of remifentanil in general anesthesia Specify the effect of intranasal and intravenous remifentanil on hemodynamic changes after induction and tracheal intubation and comparing with control group 2018-03-21 anticipated 180 Complete https://irct.ir/trial/48290 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: How to randomize in this study is done by simple randomization method using random allocation software which is an individual randomization unit and random sequencing using this software and based on the order provided to patients. For allocation concealment, the sequentially numbered ,sealed ,opaque envelopes or SNOSE method was used, Blinding description: The first person divides by simple non-random method / random allocation software into three groups with a total of 60 people.The second person in the treatment encodes 3 groups of intranasal and intravenous drugs and the same amount of normal saline volume. The other person also collects the information of each group without knowing the study group.Data analysis is also performed without the knowledge of the groups. 3 Hemodynamic changes after induction of anesthesia. Intervention 1: Intervention group: The first intervention group consisted of 60 recipients receiving 0.5 micrograms intravenous remifentanyl. Intervention 2: Intervention group: The second group includes 60 recipients of nasal Remifentanyl in the amount of 4 micrograms per kilogram. Intervention 3: Control group: Includes 60 people receiving the same amount of saline with intervention groups. Yes - There is a plan to make this available What will be shared: After completing the study, all the documents can be shared after identifying the participants in the study. When: The time period for accessing the study data is December 30, 2020 To whom: Data and other study documents will be available only to researchers working in academic and scientific institutions Conditions: Other researchers of research centers are provided with a letter of introduction from a reputable center and mention the goals ahead and the type of targeted analysis , if appropriate, information and study data can be reached. Where to obtain: By presenting a valid letter of introduction based on the priority of scientific study organizations and referring to Dr. Mohammad Reza Safavi to the address of Isfahan Al-Zahra Hospital Boulevard and e-mail address: safavi@med.mui.ac.ir How to obtain: After submitting the request to the responsible person in charge of the study, if it is approved by the research deputy of Isfahan University of Medical Sciences and the approval of the anesthesia department, the research documents will be provided to the person. Comments:
public Mohammadreza Safavi
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan Iran (Islamic Republic of) 8614736441 +98 31 1273 2659 safavi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammadreza Safavi
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan Iran (Islamic Republic of) 8614736441 +98 31 1273 2659 safavi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient with ASA1.2 Patient between 18 to 65 years old Patients who need General anesthesia and larengoscopy and tracheal intubation 18 years 65 years Both Patients under 18 or older than 65 years old Addicted patients Patients who have allergy to the drug noticed in this study Patient with ASA3.4 Treatment - Drugs Treatment - Drugs Placebo Intervention group: The first intervention group consisted of 60 recipients receiving 0.5 micrograms intravenous remifentanyl Intervention group: The second group includes 60 recipients of nasal Remifentanyl in the amount of 4 micrograms per kilogram Control group: Includes 60 people receiving the same amount of saline with intervention groups Mean systolic and diastolic blood pressure and mean arterial blood pressure. Timepoint: Basic time (just before the intervention) 1-3 minutes after anesthesia just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy. Method of measurement: Non-invasive manometer. Heart rate. Timepoint: At baseline (before the intervention) 1 to 3 minutes after anesthesia just before laryngoscopy and at 1-3-5-10 minutes after laryngoscopy. Method of measurement: electro cardiogaraph. Average of satisfaction score. Timepoint: after surgery. Method of measurement: Visual Analogue Scale. Average of O2 saturation. Timepoint: Basic time (before the intervention) 1 to 3 minutes after anesthesia just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy. Method of measurement: pulse oxymeter. Capnography. Timepoint: Basic time (before the intervention) 1 to 3 minutes after anesthesia just before laryngoscopy and 1-3-5-10 minutes after laryngoscopy. Method of measurement: capnograph. Esfahan University of Medical Sciences Approved 2020-05-17 Ethics committee of isfahan University of Medical Sciences Hezar Jerib Ave.Isfahan University of Medical Sciences isfahan Isfehan Iran (Islamic Republic of)