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IRCT20141209020258N187 IRCT 2023-07-19 Arak University of Medical Sciences Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions Investigating the effect of tracheal tube cuff pressure balancing in preventing sore throat and hoarseness in general anesthesia using nitrous oxide in surgery in supine and prone positions 2023-07-23 anticipated 212 Complete https://irct.ir/trial/71194 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the specialized assistant does not know about the prescribed drugs, and the follow-up of the patients is with the anesthesiology resident, and the analyst does not know about the grouping, and as a result, the study will be double-blind. 3 General anesthesia. Intervention 1: Intervention group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Supine oxygen and N2O are prescribed with a concentration of 50:50. Intervention 2: Intervention group2 : The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Perone oxygen and N2O are prescribed with a concentration of 50:50. Intervention 3: control group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed in appropriate timings as anesthesia maintenance. In the supine position group Oxygen and air are prescribed as 50:50. Intervention 4: control group 2: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Peron oxygen and air are prescribed as 50:50. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Esmaeel Moshiri
Valiasr hospital, Shahid Shirodi street, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 moshiri@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 30 to 60 years ASA class I and II No history of sore throat before surgery No history of drug use No history of chronic use of painkillers Insensitivity to nitrous oxide Failure to perform laparoscopic surgery Absence of upper airway infection and colds Absence of malampati more than 2 No need to use NG-tube during surgery and up to 24 hours after surgery The duration of surgery should not be less than 60 minutes and not more than 120 minutes Consent to participate in the study 30 years 60 years Both The patient's lack of consent to continue participating in the study Observing blood during suction when removing the tracheal tube For any reason, we have to perform laryngoscopy twice on the patient. Y48.2 Other and unspecified general anaesthetics Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Intervention group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Supine oxygen and N2O are prescribed with a concentration of 50:50. Intervention group2 : The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Perone oxygen and N2O are prescribed with a concentration of 50:50. control group1: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed in appropriate timings as anesthesia maintenance. In the supine position group Oxygen and air are prescribed as 50:50. control group 2: The same tracheal tube from the same brand (flexicare, made in England) is used with a low pressure cuff (tracheal tube size 7-5/7 for women and 5/7-8 tracheal tube for men) Tracheal tube cuff using Ambu device cuff pressure gage and the water is inflated to a pressure of 25 cm, so that there is no audible air leakage at the maximum inspiratory pressure. The method of induction of general anesthesia is the same in all four groups, and isoflurane (0.5-1%) and Pofol infusion at a dose of 50-100 micrograms per kg per minute, and itracurium and fentanyl are prescribed at appropriate times, also in the position group. Peron oxygen and air are prescribed as 50:50. Sore throat. Timepoint: Recovery and 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Pain Visual Analog scale. Voice horsness. Timepoint: Recovery and 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Physical examination. Mean propofol consumption. Timepoint: End of study. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2023-06-06 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)