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IRCT20200921048789N2 IRCT 2021-04-12 Artesh University of Medical Sciences Evaluation of anesthesia quality with three methods: "propofol + fentanyl " Vs "propofol + fentanyl + lidocaine" Vs "propofol + fentanyl + lidocaine + ketamine" in patients referred to the scoping ward Evaluation of cough frequency and duration of recovery with three anesthesia methods: "Propofol + Fentanyl", "Propofol + Fentanyl + Lidocaine" and "Propofol + Fentanyl + Lidocaine + Ketamine" in patients referred to the scoping ward 2021-04-21 anticipated 100 Complete https://irct.ir/trial/54948 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size in this study is at least 100 patients who will be admitted to the study by block randomization method. For this purpose, the letter A is used to place patients in the group "propofol + fentanyl", the letter B is used in the group "propofol + fentanyl + lidocaine" and the letter C is used in the group "propofol + fentanyl + lidocaine + ketamine". The size of all blocks is equal and in this three-group experiment, we use 6 blocks (including two people in group A, two people in group B and two people in group C) that were obtained using random sequence generation software. Also, in order to hide the random sequence on the participants, opaque sealed envelopes sealed with random sequences (SNOSE) are used and each sequence is recorded on a card and the cards are placed in the envelopes respectively. Based on the order of entry of eligible participants in the research, the envelopes are opened in order and the assigned group of the participant is determined, Blinding description: In this study, patients are unaware of the type of sedation drug for scoping, but the specialist physician, treatment staff, and research team are aware of the type of drug combination that was randomly selected for the patient. 3 . Intervention 1: Intervention group: Group A includes patients in whom propofol + fentanyl has been used for sedation for scoping. Propofol-lipuro: initial dose 1mg/kg and repeat dose 0.5 mg/kg every 3-5 min and Fentanyl (Rotexmedica): 0.5 mic g/kg single dose. Intervention 2: Intervention group: Group B includes patients in whom propofol + fentanyl + lidocaine have been used for sedation for scoping. Propofol-lipuro: initial dose 1mg/kg and repeat dose 0.5 mg/kg every 3-5 min and Fentanyl(rotexmedica): 0.5 mic g/kg single dose and Lidocaine (pasteur): 1.5 mg/kg single dose. Intervention 3: Intervention group: Group C includes patients in whom propofol + fentanyl + lidocaine + ketamine have been used for sedation for scoping. Propofol(lipuro): initial dose 0.5mg/kg and repeat dose 0.25 mg/kg every 3-5 min and Fentanyl (Rotexmedica): 0.25 mic g/kg single dose and Lidocaine (pasteur): 0.75 mg/kg single dose and ketamine (Rotexmedica) 0.5 mg/kg single dose. Yes - There is a plan to make this available What will be shared: Research data can be published at the end of the study after identifying individuals When: After the end of the research and publication of the article To whom: All researchers and physicians engaged in the field of anesthesia and intensive care Conditions: Only for research and treatment purposes and by mentioning the names of those involved in this study Where to obtain: By email to Dr. Mohammad Reza Rafiei at Rafiei_mohamadreza@yahoo.com How to obtain: After receiving the email, the applicant's request will be reviewed and if approved, the information will be sent to them Comments:
public Mohammadreza rafiei
Aja univercity of medical science, Etemadzadeh St., West Fatemi Ave.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 Rafiei_mohamadreza@yahoo.com Artesh University of Medical Sciences scientific Mohammadreza Rafiiei
Aja univercity of medical science, Etemadzadeh St., West Fatemi Ave.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8660 9635 Rafiei_mohamadreza@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) All patients who are candidates for scoping in 501 Army Hospital in 2021 18 years 70 years Both Age under 18 and over 70 years ASA classification 4 or 5 History of uncontrolled blood pressure History of Chronic Obstructive Pulmonary Disease (COPD) History of psychotic or neurological disorders History of seizures History of use of drugs affecting the central nervous system Pregnancy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Group A includes patients in whom propofol + fentanyl has been used for sedation for scoping. Propofol-lipuro: initial dose 1mg/kg and repeat dose 0.5 mg/kg every 3-5 min and Fentanyl (Rotexmedica): 0.5 mic g/kg single dose. Intervention group: Group B includes patients in whom propofol + fentanyl + lidocaine have been used for sedation for scoping. Propofol-lipuro: initial dose 1mg/kg and repeat dose 0.5 mg/kg every 3-5 min and Fentanyl(rotexmedica): 0.5 mic g/kg single dose and Lidocaine (pasteur): 1.5 mg/kg single dose. Intervention group: Group C includes patients in whom propofol + fentanyl + lidocaine + ketamine have been used for sedation for scoping. Propofol(lipuro): initial dose 0.5mg/kg and repeat dose 0.25 mg/kg every 3-5 min and Fentanyl (Rotexmedica): 0.25 mic g/kg single dose and Lidocaine (pasteur): 0.75 mg/kg single dose and ketamine (Rotexmedica) 0.5 mg/kg single dose. Frequency of cough. Timepoint: During and after the intervention. Method of measurement: View on the patient bed. Duration of recovery. Timepoint: After intervention. Method of measurement: View on the patient bed. O2 saturation. Timepoint: During and after the intervention. Method of measurement: view on the patient's bed. Artesh University of Medical Sciences Approved 2021-02-16 کمیته اخلاق دانشگاه علوم پزشکی ارتش جمهوری اسلامی ایران Aja univercity of medical science, Etemadzadeh St., West Fatemi Ave., Tehran Tehran Iran (Islamic Republic of)