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IRCT20240916063055N1 IRCT 2024-10-10 Shiraz University of Medical Sciences Comparison of the effect of two different anesthesia methods with Remifentanil and Dexmedetomidine on the amount of bleeding during surgery and the visual in endoscopic sinus surgeries Comparison of the effect of two different anesthesia methods with Remifentanil and Dexmedetomidine on the amount of bleeding during surgery and the visual in endoscopic sinus surgeries 2024-11-01 anticipated 50 Complete https://irct.ir/trial/79136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into 2 groups by block randomization. In this technique, 5 blocks of size 4, 6, and 8 will be selected randomly for patients of 2 groups A and B. patients will be allocated randomly and equally into 2 groups. block sequence will be prepare by www.sealedenvelope.com, Blinding description: Drugs are provided in the form of similar 50ml syringes by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind. 2-3 Endoscopic sinus. Intervention 1: Intervention group: The surgical technique is the same for all patients and will be performed by a specific surgeon, but two different anesthetic formulas are used. Remifentanil (Elixir Pharmaceutical Company) is started at an intravenous infusion rate of 0.25 μg/kg simultaneously with induction of anesthesia. After that, Midazolam (Aborehan Pharmaceutical Company) 0.04mg/kg, Fentanyl (Jahan Behbohd Company) 2µg/kg and Morphine (Alborz Daro Pharmaceutical Company) 10mg/kg as premedication and Propofol (Terman Yab Daro Company) 2-2.5µg/kg and Atracurium(Daro Pakhsh Company) 0.15mg/kg will be used to induce anesthesia. Maintenance is started with Propofol (100μg/kg/min). Intervention 2: Control group: The surgical technique is the same for all patients and will be performed by a specific surgeon, but two different anesthetic formulas are used. Dexmedetomidine (Arang daro darman Company) 1μg/kg intravenous bolus dose during 20 minutes before induction of anesthesia and then continue with infusion rate of 0.4-0.8μg/kg/hr simultaneously with induction of anesthesia. After that, Midazolam (Aborehan Pharmaceutical Company) 0.04mg/kg, Fentanyl (Jahan Behbohd Company) 2µg/kg and Morphine (Alborz Daro Pharmaceutical Company) 10mg/kg as premedication and Propofol (Terman Yab Daro Company) 2-2.5µg/kg and Atracurium(Daro Pakhsh Company) 0.15mg/kg will be used to induce anesthesia. Maintenance is started with Propofol (100μg/kg/min). No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Seyed Farnoosh Firouzi
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 f.firoozi۱۹۹۰@gmail.com Shiraz University of Medical Sciences scientific Nima Naderi
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 nima_naderi۵۴@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adult patients with ASA grade I or II (American Society of Anesthesiology classification) Adult patients between 18 and 70 years old Adult patients who are candidates for sinus endoscopy 18 years 60 years Both Allergy to the drugs used in the study Positive history of kidney, liver, addiction and bleeding diseases. Obesity (BMI > 40) J32 Chronic sinusitis Treatment - Drugs Treatment - Drugs Intervention group: The surgical technique is the same for all patients and will be performed by a specific surgeon, but two different anesthetic formulas are used. Remifentanil (Elixir Pharmaceutical Company) is started at an intravenous infusion rate of 0.25 μg/kg simultaneously with induction of anesthesia. After that, Midazolam (Aborehan Pharmaceutical Company) 0.04mg/kg, Fentanyl (Jahan Behbohd Company) 2µg/kg and Morphine (Alborz Daro Pharmaceutical Company) 10mg/kg as premedication and Propofol (Terman Yab Daro Company) 2-2.5µg/kg and Atracurium(Daro Pakhsh Company) 0.15mg/kg will be used to induce anesthesia. Maintenance is started with Propofol (100μg/kg/min). Control group: The surgical technique is the same for all patients and will be performed by a specific surgeon, but two different anesthetic formulas are used. Dexmedetomidine (Arang daro darman Company) 1μg/kg intravenous bolus dose during 20 minutes before induction of anesthesia and then continue with infusion rate of 0.4-0.8μg/kg/hr simultaneously with induction of anesthesia. After that, Midazolam (Aborehan Pharmaceutical Company) 0.04mg/kg, Fentanyl (Jahan Behbohd Company) 2µg/kg and Morphine (Alborz Daro Pharmaceutical Company) 10mg/kg as premedication and Propofol (Terman Yab Daro Company) 2-2.5µg/kg and Atracurium(Daro Pakhsh Company) 0.15mg/kg will be used to induce anesthesia. Maintenance is started with Propofol (100μg/kg/min). Bleeding during surgery. Timepoint: During the surgery. Method of measurement: Based on the estimate of sterile gases used and Measuring the volume of the suction device. Postoperative nausea and vomiting. Timepoint: Recovery and at the time of arrival and every 30 minutes. Method of measurement: Based on scoring (0=no nausea and vomiting, 1=nausea, 2=vomiting and 3=vomiting more than 2 times). Pain after surgery. Timepoint: Recovery and at the time of arrival and every 20 minutes. Method of measurement: Visual pain scale questionnaire. Blood pressure. Timepoint: During surgery every 15 minutes. Method of measurement: Monitoring. Heart rate. Timepoint: During surgery every 15 minutes. Method of measurement: Monitoring. Consent of the surgeon. Timepoint: After surgery. Method of measurement: Questionnaire. Shiraz University of Medical Sciences Approved 2024-05-04 Ethics Committee of Shiraz Medical School. 3rd Floor, 3rd bBuiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)