]>
IRCT20220301054154N1 IRCT 2022-09-20 Tabriz University of Medical Sciences The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane in children The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane in children 2021-10-02 anticipated 60 Complete https://irct.ir/trial/64177 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Through a randomly generated computer-generated list, individuals will be assigned to three intervention groups, Blinding description: In this research only the patient is unaware of the fresh gas flow. 3 The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane. Intervention 1: Intervention group: A with FGF of 2 L/min. Intervention 2: Intervention group: B with FGF of 4 L/min. Intervention 3: Intervention group: C with FGF of 6 L/min. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academia and people in industry. Conditions: There are no specific restrictions on the use of data or documentation. Where to obtain: Dr .Masoud Parish Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran oudparish@yahoo.com Phone: +98 413 3341994 How to obtain: Applicants will have access to the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Masoud Parish
Shohada Hospital, Gholshahr Avenue, Yaghchian street
Tabriz Iran (Islamic Republic of) 5167846171 +98 41 3385 5842 parishm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masoud Parish
Shohada Hospital, Golshahr Avenue, Yaghchian street
Tabriz Iran (Islamic Republic of) 5167846171 009833855842 parishm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 6 month to 8 years candidate for elective orthopedic surgery having an indication for inhalational induction of anesthesia 6 months 8 years Both lack of parental consent emergent surgery not being NPO significant cardiovascular disease pulmonary disease neurologic disorder prediction of a difficult airway or IV line facial or airway anomalies history of malignant hyperthermia in the patient or their family acute respiratory infection in the past week history of GERD T88.59 Other complications of anesthesia Treatment - Drugs Treatment - Devices Treatment - Drugs Intervention group: A with FGF of 2 L/min Intervention group: B with FGF of 4 L/min Intervention group: C with FGF of 6 L/min Duration of reaching to the Bispectral Index between 60 to 70. Timepoint: from the start point of induction untill reaching to the Bispectral Index between 60 to 70. Method of measurement: using the bispectral index monitor based on electroencephalogram waves during anesthesia, measuring time in seconds. Duration till the loss of response to squeezing the trapezius muscle. Timepoint: from the start point of induction to complete loss of response to squeezing the trapezius muscle. Method of measurement: measuring time in seconds, by physical examination and observing patient's reaction. Duration until Laryngeal Mask Airway installation. Timepoint: from the start point of induction until Laryngeal Mask Airway installation. Method of measurement: measuring time in seconds. Existence of reaction to Laryngeal Mask Airway installation. Timepoint: During Laryngeal Mask Airway insertion. Method of measurement: Observing the patient's reaction. Heart rate. Timepoint: Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway. Method of measurement: Beat Per minute using a non-invasive heart rate monitor. Blood pressure. Timepoint: Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway. Method of measurement: In millimeters of mercury using a non-invasive method of measuring blood pressure by monitoring device. Oxygen saturation. Timepoint: Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway. Method of measurement: in percent, by pulse oximeter device. Breath holding. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: observation. Coughing. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: observation. Bradycardia. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: Beat Per minute using a non-invasive heart rate monitor. Low Blood pressure. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: In millimeters of mercury using a non-invasive method of measuring blood pressure by device. Laryngospasm. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: observation. Vomiting. Timepoint: From the beginning of induction to the end of anesthesia. Method of measurement: observation. Tabriz University of Medical Sciences Approved 2021-09-28 National committee for ethics in biomedical research (Tabriz university of medical sciences) Faculty of medicine, Tabriz university of medical sciences, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)