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IRCT20120801010471N3 IRCT 2018-08-05 Sanandaj University of Medical Sciences Comparative study of the effects of Sevoflurane and Isoflurane on bleeding rate during endoscopic surgery of nasal sinus FESS Comparative study of the effects of Sevoflurane and Isoflurane on bleeding rate during endoscopic surgery of nasal sinus 2016-11-21 anticipated 46 Complete https://irct.ir/trial/29492 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Simple randomization based on random number table was done dividing patients into Isofloran and Sevofloran groups, Blinding description: The researcher and surgeon were blinded by using covered vaporizers. The anesthetist knew the type of volatile, filled the questionnaire was not blinded. 3 Effect of sevoflurane and isoflurane on bleeding rate of functional endoscopic sinus surgery. Intervention 1: 23 patients will be assigned to each group. Continuous clinical monitoring is performed with EKG, Pulse Oximetry, temperature, BP for every 3 minutes and Bispectral Index (A 2000 BIS_XP, aspect medical system INC, Norwood, MA, USA). The patients' height and weight in both groups will be evaluated at the beginning of the entry by similar devices and an anesthetics assistance. Subsequently, 5 minutes before initiation of induction, 5 mg / kg of ringer is administered. Then, 2 μ / kg of fentanyl, 0.15 mg / kg midazolam, 1 mg / kg lidocaine, 8 mg dexamethasone, and 10 mg of metoclopramide were injected in 5 minutes to the patients. Then, propofol at a dose of 2 mg / kg is administered for induction in 30 seconds. During induction, 100% oxygen was inducted to the patients. After the disappearance of lash reflex, a dose of 0.5 mg / kg bolus atracurium was injected for muscle relaxation in 30 seconds. Intracranial intubation is performed with spiral tube number 7 for women and 7.5 for men. After intubation, mechanical ventilation to reach End tidal is set Co2 25-35 mm / Hg with 50% O2 + N2O and the volume of 8cc / kg and I / E: 1/2 and peep: 0 and RR: 12. In isoflurane group is given 1 MAC during inhalation anesthetics' operation. Our goal is to reach MAP: 65 and HR: 85. And if MAP is lower than 60, 5 mg of Ephedrine bolus is prescribed. If MAP is more than 85, 50 micrograms of TNG will be injected. No other medicine will be prescribed. If for any reason we have to use another medicine, or change the patient's ventilation, and if the operation has an effect on the amount of bleeding, the patient is excluded from the study and at the end of the project, the paper will record the cause. During surgery, every 30 minutes, according to the amount of TOF, non-depolarizing muscle relaxation will be repeated based on narcotic BIS. Immediately after the completion of surgery, all medicines will be discontinued except oxygen, and the patient will be extubated after airway reflexes. Intervention 2: Control group: 23 patients will be assigned to this group. Continuous clinical monitoring is performed with EKG, Pulse Oximetry, temperature, BP for every 3 minutes and Bispectral Index (A 2000 BIS_XP, aspect medical system INC, Norwood, MA, USA). The patients' height and weight in both groups will be evaluated at the beginning of the entry by similar devices and an anesthetics assistance. Subsequently, 5 minutes before initiation of induction, 5 mg / kg of ringer is administered. Then, 2 μ / kg of fentanyl, 0.15 mg / kg midazolam, 1 mg / kg lidocaine, 8 mg dexamethasone, and 10 mg of metoclopramide were injected in 5 minutes to the patients. Then, propofol at a dose of 2 mg / kg is administered for induction in 30 seconds. During induction, 100% oxygen was inducted to the patients. After the disappearance of lash reflex, a dose of 0.5 mg / kg bolus atracurium was injected for muscle relaxation in 30 seconds. Intracranial intubation is performed with spiral tube number 7 for women and 7.5 for men. After intubation, mechanical ventilation to reach End tidal is set Co2 25-35 mm / Hg with 50% O2 + N2O and the volume of 8cc / kg and I / E: 1/2 and peep: 0 and RR: 12. In sevoflurane group is given 1 MAC during inhalation anesthetics' operation. Our goal is to reach MAP: 65 and HR: 85. And if MAP is lower than 60, 5 mg of Ephedrine bolus is prescribed. If MAP is more than 85, 50 micrograms of TNG will be injected. No other medicine will be prescribed. If for any reason we have to use another medicine, or change the patient's ventilation, and if the operation has an effect on the amount of bleeding, the patient is excluded from the study and at the end of the project, the paper will record the cause. During surgery, every 30 minutes, according to the amount of TOF, non-depolarizing muscle relaxation will be repeated based on narcotic BIS. Immediately after the completion of surgery, all medicines will be discontinued except oxygen, and the patient will be extubated after airway reflexes. Yes - There is a plan to make this available What will be shared: All of the data Provided except private data of patients When: After the submission of the article in a valid journal To whom: This is available for any researchers who interested in subject . Conditions: Any new research based on our date with cooperation would be available . Where to obtain: Dr.Milad Masaeli How to obtain: The available data should be asked in an email to let me know how i can help with this Comments:
public Milad Masaeli
Kowsar Hospital, Pasdaran ave, Sanandaj
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3361 1231 drmilmas@yahoo.com Sanandaj University of Medical Sciences scientific Milad Masaeli
Kowsar Hospital, Pasdaran ave, Sanandaj
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3361 1231 drmilmas@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Elective surgery Patients between 18 and 60 years old ASA 1,2 18 years 60 years Both BMI≥30 Alchohol user Medications that affect MAC Communication problems Fungal sinusitis Nasal polyps greater than 3 (due to increased inflammation and vascularity of the vessels that both cause increasing bleeding in the surgical field and Surgery Grade Score) Substance user Other Other 23 patients will be assigned to each group. Continuous clinical monitoring is performed with EKG, Pulse Oximetry, temperature, BP for every 3 minutes and Bispectral Index (A 2000 BIS_XP, aspect medical system INC, Norwood, MA, USA). The patients' height and weight in both groups will be evaluated at the beginning of the entry by similar devices and an anesthetics assistance. Subsequently, 5 minutes before initiation of induction, 5 mg / kg of ringer is administered. Then, 2 μ / kg of fentanyl, 0.15 mg / kg midazolam, 1 mg / kg lidocaine, 8 mg dexamethasone, and 10 mg of metoclopramide were injected in 5 minutes to the patients. Then, propofol at a dose of 2 mg / kg is administered for induction in 30 seconds. During induction, 100% oxygen was inducted to the patients. After the disappearance of lash reflex, a dose of 0.5 mg / kg bolus atracurium was injected for muscle relaxation in 30 seconds. Intracranial intubation is performed with spiral tube number 7 for women and 7.5 for men. After intubation, mechanical ventilation to reach End tidal is set Co2 25-35 mm / Hg with 50% O2 + N2O and the volume of 8cc / kg and I / E: 1/2 and peep: 0 and RR: 12. In isoflurane group is given 1 MAC during inhalation anesthetics' operation. Our goal is to reach MAP: 65 and HR: 85. And if MAP is lower than 60, 5 mg of Ephedrine bolus is prescribed. If MAP is more than 85, 50 micrograms of TNG will be injected. No other medicine will be prescribed. If for any reason we have to use another medicine, or change the patient's ventilation, and if the operation has an effect on the amount of bleeding, the patient is excluded from the study and at the end of the project, the paper will record the cause. During surgery, every 30 minutes, according to the amount of TOF, non-depolarizing muscle relaxation will be repeated based on narcotic BIS. Immediately after the completion of surgery, all medicines will be discontinued except oxygen, and the patient will be extubated after airway reflexes. Control group: 23 patients will be assigned to this group. Continuous clinical monitoring is performed with EKG, Pulse Oximetry, temperature, BP for every 3 minutes and Bispectral Index (A 2000 BIS_XP, aspect medical system INC, Norwood, MA, USA). The patients' height and weight in both groups will be evaluated at the beginning of the entry by similar devices and an anesthetics assistance. Subsequently, 5 minutes before initiation of induction, 5 mg / kg of ringer is administered. Then, 2 μ / kg of fentanyl, 0.15 mg / kg midazolam, 1 mg / kg lidocaine, 8 mg dexamethasone, and 10 mg of metoclopramide were injected in 5 minutes to the patients. Then, propofol at a dose of 2 mg / kg is administered for induction in 30 seconds. During induction, 100% oxygen was inducted to the patients. After the disappearance of lash reflex, a dose of 0.5 mg / kg bolus atracurium was injected for muscle relaxation in 30 seconds. Intracranial intubation is performed with spiral tube number 7 for women and 7.5 for men. After intubation, mechanical ventilation to reach End tidal is set Co2 25-35 mm / Hg with 50% O2 + N2O and the volume of 8cc / kg and I / E: 1/2 and peep: 0 and RR: 12. In sevoflurane group is given 1 MAC during inhalation anesthetics' operation. Our goal is to reach MAP: 65 and HR: 85. And if MAP is lower than 60, 5 mg of Ephedrine bolus is prescribed. If MAP is more than 85, 50 micrograms of TNG will be injected. No other medicine will be prescribed. If for any reason we have to use another medicine, or change the patient's ventilation, and if the operation has an effect on the amount of bleeding, the patient is excluded from the study and at the end of the project, the paper will record the cause. During surgery, every 30 minutes, according to the amount of TOF, non-depolarizing muscle relaxation will be repeated based on narcotic BIS. Immediately after the completion of surgery, all medicines will be discontinued except oxygen, and the patient will be extubated after airway reflexes. Bleeding rate on endoscopic sinus surgery. Timepoint: The measurement of the amount of bleeding is evaluated with the mass of used sterilized gases using a calibrated scale each day and the amount of blood accumulated in the suction in cc .and after 60 minutes through Grade Score, the surgeon also evaluates the amount of bleeding during the surgery. Method of measurement: Grade Assessment : 0 = No bleeding (Cadaveric conditions). 1= Slight bleeding - no suctioning required. 2= Slight bleeding - occasional suctioning required.3 = light bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed. Sanandaj University of Medical Sciences Approved 2017-05-28 Ethical Committee Of Kurdistan University Of Medical Science Pasdaran Sanandaj Kurdistan Iran (Islamic Republic of)