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IRCT20110103005536N8 IRCT 2020-09-11 Artesh University of Medical Sciences Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base in patients refered at lung clinic in AJA 501 hospital 2019-05-22 anticipated 140 Complete https://irct.ir/trial/50426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned between the two groups (70 people in each group) by Simple Random Sampling method using black and white cards, so that patients with black card to group one, and patients with white card to Group two is assigned and this process is repeated again, Blinding description: In this study, neither the patient nor the collector knew how the samples were distributed. The obtained information is then statistically analyzed by the person in charge of statistical work who does not know how the patients are distributed. N/A bronchoscopy. Intervention 1: Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia is used based on "midazolam". It is administered intravenously and after the fibroptic bronchoscope enters the patient's mouth and before passing through the vocal cords with a syringe with a volume of 5 cc of distilled water is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and then After passing the bronchoscope through the vocal cords, a syringe with a volume of 5 cc of distilled water is poured into the patient's trachea (tracheobronchial tree). Intervention 2: Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia based on "lidocaine" is used. A syringe containing 5 cc of lidocaine (2% lidocaine) is used intravenously and after entering the fibroptic bronchoscope. Patient and before passing the vocal cords with a syringe with a volume of 5 cc lidocaine 2% is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and after passing the bronchoscope through the vocal cords with a syringe With a volume of 5 cc of 2% lidocaine is poured into the patient's trachea (tracheobronchial tree). Yes - There is a plan to make this available What will be shared: All data can be shared after it is unrecognizable When: Start the access period after printing the results To whom: All researchers and colleagues in this field Conditions: For therapeutic-research purposes and by mentioning the names of the authors of the article Where to obtain: Dr. mohammadreza rafiei How to obtain: Sending an Email to Dr. mohammadreza rafiei and receive data and documentation if needed in the shortest time Comments:
public Dr. Mohammadreza Rafiei
Etemadzadeh St., West Fatemi Ave.
Tehran Iran (Islamic Republic of) 8158177365 +98 31 3261 6302 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences scientific Dr. Mohammadreza Rafiei
Etemadzadeh St., West Fatemi Ave.
Tehran Iran (Islamic Republic of) 8158177365 +98 31 3261 6302 mo_rafiei@armyums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) male and female patients aged 18 to 80 years ASA I-II 18 years 80 years Both People with a history of sore throat and lung disease with 90% o2sat (hypoxemia) People with Ejection fraction less than 40% people with hearth rate less than 50 people with hypotension less than 90 mmHg People with III and grade II conduction blocks People with liver failure (2-fold increase in liver enzymes) and kidney failure (creatinine more than 2 mg / dL) Pregnant or lactating women People With a history of long-term use of antipsychotic drugs or sedatives. Treatment - Other Treatment - Other Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia is used based on "midazolam". It is administered intravenously and after the fibroptic bronchoscope enters the patient's mouth and before passing through the vocal cords with a syringe with a volume of 5 cc of distilled water is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and then After passing the bronchoscope through the vocal cords, a syringe with a volume of 5 cc of distilled water is poured into the patient's trachea (tracheobronchial tree). Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia based on "lidocaine" is used. A syringe containing 5 cc of lidocaine (2% lidocaine) is used intravenously and after entering the fibroptic bronchoscope. Patient and before passing the vocal cords with a syringe with a volume of 5 cc lidocaine 2% is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and after passing the bronchoscope through the vocal cords with a syringe With a volume of 5 cc of 2% lidocaine is poured into the patient's trachea (tracheobronchial tree). Type of basic anesthetic. Timepoint: Before the intervention. Method of measurement: Based on the name of the drug. Complications of bronchoscopy. Timepoint: During the intervention. Method of measurement: Based on the need for intubation, nausea, decreased oxygen saturation, sore throat, cough. Duration of bronchoscopy. Timepoint: During the intervention. Method of measurement: Based on time from start to end of the procedure. Physician satisfaction. Timepoint: After the intervention. Method of measurement: Based on the doctor's satisfaction with the procedure from 1 to 5 based on likret scale. Patient satisfaction. Timepoint: After the intervention. Method of measurement: Based on the patient's satisfaction with the procedure from 1 to 5 based on likret scale. Artesh University of Medical Sciences Approved 2019-04-28 Ethics committee of aja univercity of medical sciences Etemadzadeh St., West Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)