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IRCT20180416039326N22 IRCT 2023-06-11 Esfahan University of Medical Sciences The effect of three different methods of laryngeal mask insertion (LMA) on cardiovascular response The effect of laryngeal mask insertion (LMA) with classical methods, triple maneuver and rotation on cardiovascular response 2023-02-20 anticipated 90 Complete https://irct.ir/trial/68622 observational Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the table of random numbers obtained from the Random Allocation software, patients are randomly assigned to one of the LMA insertion groups using the classic method, the triple maneuver method, and the rotation method, and are included in the study. https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html, Blinding description: In this study, the patient and the person collecting the data will be unaware of the laryngeal mask airway placement method. N/A effect of oropharyngeal stimulation on cardiovascular response during laryngeal mask airway implantation. Intervention 1: Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of classic method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Intervention 2: Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of triple maneuver method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Intervention 3: Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of rotational method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: There are no special conditions Where to obtain: hamidshetabi@med.mui.ac.ir How to obtain: The request will sent to the researcher and the information is provided after checking Comments:
public Hamidreza Shetabi
Soffeh BLVD. Alzahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 8222532 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Modarres st.feiz hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3620 2020 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Older than 18 years old l or ll physical condition based on American Society of Anaesthesiologists Informed consent of participate in research Candidate patients for airway management using a laryngeal mask airway 18 years no limit Both People with difficult airway with mouth inlet less than 2.5 cm or difficult intubation (mallampati>۳ ، TMD< ۶.۵) People at high risk of aspiration include non-fasting, GERD sufferers, and pregnant people Patient with a history of sore throat in the last month History of the common cold in the last 10 days History of head and neck or stomach surgery Coagulopathies BMI>30 Uncontrolled cardiovascular, pulmonary and liver disease Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of classic method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of triple maneuver method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Intervention group: According to the weight of patients, LMA size 3 (weight less than 50 kg) or size 4 (weight 70-50 kg) or size 5 (weight 71 kg or more) is selected and according to the principles of rotational method, the mask will be placed in the sniffing position. The person placing the LMA masks has at least two years of experience in this field. Mean atrial pressure. Timepoint: Basic time and in 1, 3, and 5 minutes after installing the laryngeal mask. Method of measurement: Blood pressure monitor. Heart rate. Timepoint: Basic time and in 1, 3, and 5 minutes after installing the laryngeal mask. Method of measurement: Heart monitor. Arterial O2 saturation. Timepoint: Basic time and in 1, 3, and 5 minutes after installing the laryngeal mask. Method of measurement: Pulse oximeter device. Esfahan University of Medical Sciences Approved 2023-01-02 Ethical Committee of Isfahan University of Medical Sciences No. 4, 3rd Sajjadiyeh Alley, Artesh Blvd, Farahabad Isfahan Isfehan Iran (Islamic Republic of)