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IRCT20120910010800N4 IRCT 2022-04-23 Shahid Beheshti University of Medical Sciences Evaluation of the effect of using local anesthetics inside the endotracheal tube cuff on emergence reactions from anesthesia Comparative evaluation of intracuff ropivacaine, bupivacaine, and lidocaine on emergence reactions after general anesthesia 2022-04-20 anticipated 350 Complete https://irct.ir/trial/62796 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are grouped by a simple randomization method using a random selection of one of the five cards, each of which is named after one of the groups, Blinding description: Before performing anesthesia, an anesthesia technician, without the knowledge of the anesthesiologist and the patient, uses a random selection of a card to identify the patient group and deliver one of the syringes containing one of the drugs in each group to the anesthesiologist and record this information separately. At the end of the surgery, the questionnaire is delivered to the first technician. Information outside the operating room is tracked by the same anesthesiologist. 3 Cough, sore throat, and hoarseness after extubation. Intervention 1: Control group: In the air group, the endotracheal tube's cuff will be filled with a minimum volume of air so that no sound of air leakage can be heard. Intervention 2: Intervention group: In the isotonic saline solution group, the cuff of the endotracheal tube will be filled with a minimum volume of isotonic saline solution so that no air leakage sound can be heard. Intervention 3: Intervention group: In the ropivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% ropivacaine so that no air leakage can be heard.ine. Intervention 4: Intervention group: In the bupivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% bupivacaine so that no air leakage can be heard.ine. Intervention 5: Intervention group: In the lidocaine group, the endotracheal tube's cuff will be filled with a minimum volume of 2% lidocaine so that no air leakage can be heard.ine. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: One year after the publication of the article. To whom: All jobs Conditions: All non-personal patient information (anonymously) can be accessed by contacting the responsible author. Where to obtain: email to: drdariushabtahi@yahoo.com How to obtain: Sending email and review by the responsible author Comments:
public Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dariush Abtahi
Emam Hossein Hospital. Shahid Madani St.
Tehran Iran (Islamic Republic of) 1617763141 009812277567840 drdariushabtahi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age older than 18 years old Consent to the study Performing general anesthesia using endotracheal intubation 18 years no limit Both Drug abuse Existence of uncontrolled underlying disease Pre-existing sore throat Pre-existing hoarseness Pre-existing cough Recent respiratory infection History of hyperactive airways History of prolonged intubation Anticipated difficult intubation Risk of aspiration of gastric contents T88.9XXA Complication of surgical and medical care, unspecified, initial encounter Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: In the air group, the endotracheal tube's cuff will be filled with a minimum volume of air so that no sound of air leakage can be heard. Intervention group: In the isotonic saline solution group, the cuff of the endotracheal tube will be filled with a minimum volume of isotonic saline solution so that no air leakage sound can be heard. Intervention group: In the ropivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% ropivacaine so that no air leakage can be heard.ine Intervention group: In the bupivacaine group, the endotracheal tube's cuff will be filled with a minimum volume of 0.5% bupivacaine so that no air leakage can be heard.ine Intervention group: In the lidocaine group, the endotracheal tube's cuff will be filled with a minimum volume of 2% lidocaine so that no air leakage can be heard.ine Cough. Timepoint: At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation. Method of measurement: Anesthesiologist observation to determine its presence and severity (mild: less than 5 coughs, moderate: more than 5 coughs, severe: frequent coughs that prevent the patient from breathing normally). Sore throat. Timepoint: At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation. Method of measurement: Patient self-reported based on either three, moderate, or severe levels. Hoarseness. Timepoint: At zero, ten minutes, thirty minutes, 6 hours, and 24 hours after extubation. Method of measurement: Observe an anesthesiologist by determining its presence and severity (mild: ability to speak easily with slight change in voice, moderate: difficulty speaking, severe: complete hoarseness). Shahid Beheshti University of Medical Sciences Approved 2019-05-05 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)