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IRCT20230716058802N1 IRCT 2023-07-29 Khoram-Abad University of Medical Sciences Comparison of two methods of Laryngeal Mask Airway insertion,Classic method and using a Laryngoscope. Comparison of two methods of LMA insertion,Classic method and using a Laryngoscope. 2023-08-05 anticipated 106 Complete https://irct.ir/trial/71413 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on consecutive non-probability sampling, based on the order of hospitalization, eligible patients are sampled. In this way, the classes are made based on the age groups and gender of the patient (four classes in total). Within each class, random permutation block method is used to assign to two groups. The random tool will also be a table of random numbers. Due to the nature of the anesthesia technique, it was not used in this research. The initial sample size was 44 people in each group using the variable of pain severity and based on the statistical formula, and finally, taking into account the probability of 20% dropout, the final sample size was 53 people in each group (106 in total). N/A Comparison of two methods of LMA insertion,Classic method and using a Laryngoscope.. Intervention 1: Control group: Placing the LMA mask in the classic way: In this method, the LMA mask is inserted into the patient's mouth by the doctor's index finger, and then it is sent to the patient's throat in the hypopharynx area in the form of a midline while in direct contact with the patient's mouth and tongue. so that the tip of the mask is in contact with the esophagus, until it finally reaches a real resistance. Intervention 2: Intervention group: placement of LMA using laryngoscope: in this method, first we extend the patient's head back, after opening the patient's mouth, we insert the laryngoscope from the right side of the patient's mouth and open the oral space and after accessing the vision Appropriately, we fix the LMA in its anatomical position in the hypopharynx area. In this method, the patient does not undergo a laryngoscopy and the laryngoscope is used only to open the oral space and have a better view. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: 6 months after the results are published To whom: University researchers Conditions: Scientific use Where to obtain: Lorestan University of Medical Sciences website How to obtain: Clear request of the applicant on the website of Lorestan University of Medical Sciences to access the data and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Aram Azizi
No36,Saba street,Keyo squre
Khorramabad Iran (Islamic Republic of) 6817744491 +98 66 3321 5410 aram.azizi0212@yahoo.com Khoram-Abad University of Medical Sciences scientific Aram Azizi
No36, Saba street,Keyo square
Khorramabad Iran (Islamic Republic of) 6817744491 +98 66 3321 5410 aram.azizi0212@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Elective surgery patients in Khorramabad Ashayer Hospital ,in 1402, Patients with ASA class 1 and 2. Patients with minor surgery. Patients aged 18 to 65 years Informed patients with written consent 18 years 65 years Both Patients with head and face injuries and head and neck abnormalities Patients who have contraindications for LMA placement: such as high risk of aspiration, not fasting, pregnancy Patients with difficult Airway Treatment - Devices Treatment - Devices Control group: Placing the LMA mask in the classic way: In this method, the LMA mask is inserted into the patient's mouth by the doctor's index finger, and then it is sent to the patient's throat in the hypopharynx area in the form of a midline while in direct contact with the patient's mouth and tongue. so that the tip of the mask is in contact with the esophagus, until it finally reaches a real resistance. Intervention group: placement of LMA using laryngoscope: in this method, first we extend the patient's head back, after opening the patient's mouth, we insert the laryngoscope from the right side of the patient's mouth and open the oral space and after accessing the vision Appropriately, we fix the LMA in its anatomical position in the hypopharynx area. In this method, the patient does not undergo a laryngoscopy and the laryngoscope is used only to open the oral space and have a better view. Number of attempts to successfully insert LMA. Timepoint: After LMA placement. Method of measurement: Observe. Duration of placement of LMA. Timepoint: After LMA placement. Method of measurement: Observe. Presence of blood on the LMA. Timepoint: After removing the LMA. Method of measurement: Observe. Presence of air in the stomach. Timepoint: After removing the LMA. Method of measurement: Abdominal examination. Severity of sore throat after surgery based on the VAS criterion. Timepoint: After the surgery is completed and the patient becomes conscious. Method of measurement: interview. Tooth damage. Timepoint: After LMA placement. Method of measurement: Observe. Doctor's satisfaction rate. Timepoint: After LMA placement. Method of measurement: Interview. Khoram-Abad University of Medical Sciences Approved 2023-07-11 Ethic committee of Lorestan University of Medical Sciences Dorud Khorramabad highway,Kmalvand,Lorestan University of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)