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IRCT20220222054094N1 IRCT 2022-02-27 Sanandaj University of Medical Sciences Comparison of the effect of dexmedetomedine and remifentanil in reducing paranasal sinus surgery bleeding Comparison of the effect of dexmedetomedine and remifentanil in reducing paranasal sinus surgery bleeding: a double-blind randomized clinical trial 2022-04-04 anticipated 100 Complete https://irct.ir/trial/62178 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 ( intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group), Blinding description: To blind the study, patients do not know which study groups they are in. Also, the prepared medication (dexmedetomidine or remifentanil), in the same volume and appearance, is prepared and coded by a nurse colleague who is not present in the study. The anesthesiologist who also performs the procedure is not aware of the prescription drug and the grouping of patients. Patients will be evaluated by an anesthesia assistant who is not in the study group. 3 Bleeding during paranasal sinus surgery. Intervention 1: Intervention group: After anesthesia induction in a similar plan, patients will receive dexmedetomidine (Precedex- Pfizer) at a dose of 0.2 μg / kg per hour as an infusion. Intervention 2: Intervention group: After anesthesia induction in a similar plan, patients will receive remifentanil (Ultiva - Mylan) at a dose of 0.25 μg / kg / min as an infusion. 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 Behzad Ahsan
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 66177-13663 +98 87 3361 1231 behzadahsan@gmail.com Sanandaj University of Medical Sciences scientific Behzad Ahsan
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 66177-13663 +98 87 3361 1231 behzadahsan@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 18 to 45 years Patient in class 1 or 2 ASA physical status Patients who have referred for para-nasal sinus surgery, septoplasty and rhinoplasty 18 years 45 years Both History of heart disease, hypertension, kidney, liver and lung and blood coagulation disorders History of mental health problems Patients receiving anti-hypertensive drugs Patients receiving NSAIDs Patients with a BMI greater than 30 Treatment - Drugs Treatment - Drugs Intervention group: After anesthesia induction in a similar plan, patients will receive dexmedetomidine (Precedex- Pfizer) at a dose of 0.2 μg / kg per hour as an infusion. Intervention group: After anesthesia induction in a similar plan, patients will receive remifentanil (Ultiva - Mylan) at a dose of 0.25 μg / kg / min as an infusion. Bleeding. Timepoint: Intervals of 15 minutes during surgery. Method of measurement: The amount of bleeding during the operation will be recorded based on the surgeon's comments and according to the quality of the surgical field, as well as the amount of bleeding based on the 5-point Likert scale in 15-minute intervals during the surgery.Score 1: Uncontrolled bleeding, Score 2: Severe bleeding, surgical field is distorted immediately after suction, Score 3: Moderate bleeding, frequent suction required, vision in the surgical field is moderate,Score 4: Minor bleeding, occasional suction required, vision in the surgical field is good,Score 5: No bleeding in the surgical field, almost bloodless. The amount of blood sucked in the suction bottle will also be measured (by calculating the amount of serum used for washing and reducing it from the total volume). Blood gases will also be weighed at the end of the operation using a heat scale. Pain. Timepoint: Recovery period and every 2 hours to 6 hours after the recovery period. Method of measurement: Using the Visual Analogue Scale (VAS), which is a numerical scoring scale (zero painless to 10 highest pain), based on patient's statement. Vital sign (Mean arterial pressure, heart rate and SPo2). Timepoint: Mean arterial pressure, heart rate and SPo2 will be recorded at 1 minute after intubation and then every 5 minutes to half an hour and then every 15 minutes until the end of the syrgery. It will also be measured at 15 minute intervals during the recovery period. Method of measurement: Patient bedside monitoring device(Non invasive blood pressure, Pulse oximetry ). Sedation - Agitation. Timepoint: At Recovery period. Method of measurement: Using the 7-point sedation-Agitation Scale (Riker). Sanandaj University of Medical Sciences Approved 2022-01-25 Research Ethics Committees of Kurdistan University of Medical Sciences Pasdaran Blvd Sanandaj Kurdistan Iran (Islamic Republic of)