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IRCT20230825059253N1 IRCT 2024-02-03 Research assistant of Mashhad University of Medical Sciences The effect of reducing the size of the intubation tube on the amount of sore throat after surgery comparing the use of tracheal tube size 7.5 and 6.5 in men and 7 and 6 in women during laparoscopic surgery in terms of reducing the incidence of sore throat and hoarseness after intubation 2023-09-23 anticipated 140 Complete https://irct.ir/trial/72352 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is done based on the last digit of the file number, and in patients with an even file number, a larger tube size is used, and in patients with an odd file number, a smaller tube size is used, Blinding description: In this study, only the study participants are unaware of the size of the tube used, and due to the fact that the variable is the size of the tube, there is no possibility of blinding the clinical caregiver. 3 Sore throat after surgery. Intervention 1: The first intervention group consists of men who meet the conditions for entering the study, for whom we place an endotracheal tube number 6.5, which are compared with the control group of men who are placed with an endotracheal tube number 7.5. Intervention 2: Intervention group: The second intervention group includes women who meet the conditions for entering the study, for whom we place an endotracheal tube number 6, which are compared with the control group of women who are placed with an endotracheal tube number 7. Intervention 3: Control group: The first control group of men with conditions for entering the study, for whom we place an endotracheal tube No. 7.5, which are compared to the first intervention group for which we place an endotracheal tube No. 6.5. Intervention 4: Control group: The second control group of women with conditions to enter the study, for whom we place an endotracheal tube number 7, which are compared to the second intervention group for which we place an endotracheal tube number 6. Yes - There is a plan to make this available What will be shared: All data will be published in the form of a research plan after deidentifying the individuals, which includes all the variables and outcomes of the study. When: After collecting the data and analyzing the statistics, which is about the year 1403, it will be published in the form of a research project. To whom: The data is accessible to all people, including researchers, institutions, universities, and industrial companies Conditions: The information and results of the study and data are accessible to other researchers on the condition of mentioning the source of the information and data Where to obtain: In order to receive the data, one should be in contact with the direct manager of the project, Mr. Dr. Pouria Namei, with the email address namaeip4001@mums.ac.ir, and if there are necessary conditions, the information will be provided to the people. How to obtain: If there is a request, an official letter of request and conditions should be sent to the email address namaeip4001@mums.ac.ir. If the necessary conditions are met, correspondence will be done with the person or institution within a week through this email to send the data. Comments:
public Pooria Namaei
Kaveh Blvd., Anuri St., Anuri 2, No. 20
Mashhad Iran (Islamic Republic of) 9177795915 +98 51 3840 2776 namaeip@mums.ac.ir Mashhad University of Medical Sciences scientific Masoume Tabari
Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9137913131 +98 51 3843 3999 tabarim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 18-60 years old candidates for laparoscopic surgery BMI below 35 ASA I or II clinical status. 18 years 60 years Both history of allergies and respiratory diseases history of respiratory infection during the last month History of cold or respiratory infection in the last month History of esophageal reflux Patients who fall into four Cormak-Lehane classifications during laryngoscopy Any disturbance in hemodynamics or oxygen delivery to the patient during anesthesia Need more than two laryngoscopy directions for intubation Even in patients with a BMI below 35, if re-intubation is needed due to the need to replace the tracheal tube due to overinflation Patients whose surgery lasts more than 3 hours J04.0 Acute laryngitis Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices The first intervention group consists of men who meet the conditions for entering the study, for whom we place an endotracheal tube number 6.5, which are compared with the control group of men who are placed with an endotracheal tube number 7.5. Intervention group: The second intervention group includes women who meet the conditions for entering the study, for whom we place an endotracheal tube number 6, which are compared with the control group of women who are placed with an endotracheal tube number 7. Control group: The first control group of men with conditions for entering the study, for whom we place an endotracheal tube No. 7.5, which are compared to the first intervention group for which we place an endotracheal tube No. 6.5. Control group: The second control group of women with conditions to enter the study, for whom we place an endotracheal tube number 7, which are compared to the second intervention group for which we place an endotracheal tube number 6. Evaluation of postoperative sore throat and voice severity (according to the patient's statement). Timepoint: at 1, 6, and 24 hours after surgery. Method of measurement: based on VAS criteria. Mashhad University of Medical Sciences Approved 2023-07-24 Educational, Research and Treatment Center of Imam Reza Hospital - Mashhad University of Medical Sci No. 20, Shahid Kaveh St., Malek Shaara St., Anuri St., 2 Anuri St mashhsd Razavi Khorasan Iran (Islamic Republic of)