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IRCT20230719058846N1 IRCT 2023-10-31 Karaj University of Medical Sciences Comparison of magnesium sulfate and lidocaine spray on hemodynamic changes due to laryngoscopy Comparison of the effect of magnesium sulfate and lidocaine spray on hemodynamic changes due to laryngoscopy and Tracheal intubation - Clinical trial 2023-11-21 anticipated 100 Complete https://irct.ir/trial/71449 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random Method : Simple Randomization Unit : Individual Randomization Tool : Using random cards A and B 50 cards A and 50 cards B that have the same appearance are placed in a container without the letters in the card being visible from outside. The study subjects take a card from the inside of the container and are classified into lidocaine or magnesium sulfate depending on the selected card. The selection of the card is permutation free and the card removed will not be placed in the container again. The study subjects will not know the letters in the cards and which of the drugs they are studying. Also, the subjects in the study will not be related to each other, Blinding description: The sprays are uniformed and covered in appearance, and the performer, who is the executor of the project, and the person recording the results do not know about the substance inside them. 2 Hemodynamic changes including heart rate and blood pressure and ECG changes after laryngoscopy. Intervention 1: Intervention group: In one of the studied patients, 5 puffs of lidocaine 10% containing 10 mg of lidocaine is sprayed in the throat. In the next step for both groups of atracurium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women pipe seven with Macintosh laryngoscope blade 4 will be used after laryngoscopy to measure changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10. Intervention 2: Intervention group: In one group of patients, 5 puffs of magnesium sulfate spray 20% in the enclave. In the next step for both groups of atrophorium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women tube seven with blade laryngoscope macintosh 4 After laryngoscopy, we measure and record changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10. Yes - There is a plan to make this available What will be shared: The whole data is potentially shareable after making people unidentifiable. When: Beginning of access period 6 months after publication of results To whom: Researchers working in academic and scientific institutions and people working in industry Conditions: For other scientific and research studies Dastva Studies and Measures Use in medical centers Where to obtain: Executor of Dr. Khalaji with Email Address mar_k98@yahoo.com How to obtain: Send an email to the project's executor Introducing the requesting person and organization Explanation of the purpose of the individual or organization of access to information Comments:
public Dr.Banafsheh Mashak
Kamali Medical Center, Kamali St., Shohada Sq., Shahid Beheshti St., Karaj Province, Iran
karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 mashakbanafsheh@yahoo.com Karaj University of Medical Sciences scientific Dr.Banafsheh Mashak
Kamali Medical Center, Kamali St., Shohada Sq., Shahid Beheshti St., Karaj Province, Iran
karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 mashakbanafsheh@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) All patients aged 18 to 40 years old who are in ASA (American Society Anesthesiology) Class I,II. BMI is in the range of 19 to 25 Have a mallampaty score of one or two 18 years 40 years Both 1. Patient dissatisfaction or withdrawal from participation in the study 2. Having sensitivity to magnesium sulfate and lidocaine 3. Being a smoker 4. Having a cold, cough and sputum 5.Have a mallampaty score of three or four 6. In terms of airway examination in the Lemon Law criteria have problem of intubation and diffusion should have. 7.If the laryngoscopy lasts longer than 15 seconds. If there is a problem during laryngoscopy and the patient has a difficult intubation. 8. Having a history of arterial hypertension, tachycardia, bradycardia and arrhythmia 9. Use of hemodynamic drugs such as indral and ... I97.8 Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: In one of the studied patients, 5 puffs of lidocaine 10% containing 10 mg of lidocaine is sprayed in the throat. In the next step for both groups of atracurium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women pipe seven with Macintosh laryngoscope blade 4 will be used after laryngoscopy to measure changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10 Intervention group: In one group of patients, 5 puffs of magnesium sulfate spray 20% in the enclave. In the next step for both groups of atrophorium relaxant 0.75 mg/kg and after 3 minutes the patient will be laryngoscopy and intubation (intubation is done by expert and maximum within 15 seconds and for men tube eight and for women tube seven with blade laryngoscope macintosh 4 After laryngoscopy, we measure and record changes in heart rate and blood pressure and ECG changes in minutes 1, 3, 5, 7 and 10. Systolic and diastolic blood pressure. Timepoint: Minutes 1, 3, 5, 7 and 10 from the start of the intervention. Method of measurement: Operating Room Pressure Gauge. Heart rate. Timepoint: Minutes 1, 3, 5, 7 and 10 from the start of the intervention. Method of measurement: Heart Rate Indicator Device in Operating Room. Changes in ECG. Timepoint: Minutes 1, 3, 5, 7 and 10 from the start of the intervention. Method of measurement: Electrocardiogram Monitor. Karaj University of Medical Sciences Approved 2023-06-09 Ethics committee of Alborz University of Medical Sciences No. 5,West 3rd Alley,12 meters of Boostan St, Danesh St, Central Jannatabad, Tehran, Iran tehran Tehran Iran (Islamic Republic of)