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IRCT20200825048515N71 IRCT 2023-10-08 Esfahan University of Medical Sciences Effect of respiratory tidal volume on the required dose of remifentanil to create controlled hypotension The effect of respiratory tidal volume on the required dose of remifentanil to create controlled hypotension in rhinoplasty surgery 2023-10-22 anticipated 40 Complete https://irct.ir/trial/72656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 40 eligible rhinoplasty candidate patients are randomly selected. For this, the letter A is written on 20 sheets and the letter B is written on 20 sheets, and each of them is placed in an envelope. Each patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: In order to achieve the double-blind study, the respiratory tidal volume is determined by another person not present in the study, and then the appropriate dose of remifentanil is prescribed to cause hypotension. The researcher is not aware of the difference in respiratory tidal volume in two groups. In addition, the patient, the person recording the clinical and basic information of 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. 2-3 Rhinoplasty. Intervention 1: First intervention group: In this group, the minimum tidal volume is selected based on the ideal weight (6 cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight. Intervention 2: The second intervention group: In this group, the maximum current volume is selected based on the ideal weight (10cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Alireza Hoghooghi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alireza.hoghooghy@gmail.com Esfahan University of Medical Sciences scientific Alireza Hoghooghi
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alireza.hoghooghy@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Candidate patients for rhinoplasty Age group 18-65 years Weight more than 50 kg American Society of Anesthesiologists (ASA) class is equal to I Informed consent to participate in the study 18 years 65 years Both Being addicted to opioid products Having the comorbidity (such as respiratory and coagulation disease) History of allergy to the studied drug J34 Other and unspecified disorders of nose and nasal sinuses Treatment - Drugs Treatment - Drugs First intervention group: In this group, the minimum tidal volume is selected based on the ideal weight (6 cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight. The second intervention group: In this group, the maximum current volume is selected based on the ideal weight (10cc/kg). Then remifentanil (according to routine) is given to cause hypotension and the appropriate dose is determined according to the patient's average blood pressure based on ideal body weight. Blood pressure. Timepoint: Before surgery, immediately before anesthesia and every 10 minutes during surgery until the end of surgery. Method of measurement: Monitoring device. Blood pressure. Timepoint: Before surgery, immediately before anesthesia and every 10 minutes during surgery until the end of surgery. Method of measurement: Monitoring device. Satisfaction. Timepoint: End of surgery. Method of measurement: Visual Analogue Scale (VAS). Isfahan University of Medical Sciences Approved 2023-03-29 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)