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IRCT20150317021497N7 IRCT 2022-07-16 Rafsanjan University of Medical Sciences Comparing effect of Dexmedetomidine and Labetalol on Intraoperative blood loss in Rhinoplasty Comparing effect of Dexmedetomidine and Labetalol on Intraoperative blood loss and surgical field quality in Rhinoplasty: A double-Blinded Clinical Trial 2022-07-23 anticipated 30 Complete https://irct.ir/trial/64669 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the operating room, people will be placed in study groups by lottery. Numbers 1 and 2 are written on a piece of paper and placed in sealed envelopes. The first patient will open the first envelope. If the number 1 comes out of the envelope, it is placed in the dexmedetomidine group, and of course the second person is placed in the labetalol group, and if the number 2 comes out, it is placed in the labetalol group, and the next person is placed in the dexmedetomidine group, and this process will continue until the end of the study, Blinding description: In this study, the project partner who evaluates the hemodynamic indicators does not know about the grouping of people. Also, the data analyst does not know about the grouping of people and the data will be provided to him as a number. 3 Condition 1: Systolic blood pressure. Condition 2: Diastolic blood pressure. Condition 3: Heart rate per minute. Condition 4: Mean arterial pressure. Condition 5: Bleeding rate. Intervention 1: Intervention group: Dexmedetomidine in the form of a vial of 200 micrograms in 2 cc has a sympatholytic effect and is used as an infusion at a dose of 1 microgram per kilogram of body weight in 100 cc of normal saline to induce controlled hypotension during anesthesia according to the patient's needs. Intervention 2: Intervention group:Labetalol vial 20 cc contains 5 mg in each cc and is an alpha and beta adrenergic blocker and causes blood pressure reduction with the mechanism of reducing peripheral vascular resistance while preventing the reflex increase of heart rate. It is a fast-acting drug that reaches its peak effect within 5 minutes. It is used in divided doses of 5 mg/cc, maximum 20 mg during anesthesia for one and a half to two hours according to the patient's needs for controlled hypotension. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Commitment to the principle of fiduciary Where to obtain: Sending an official letter to the Research Vice-Chancellor of Rafsanjan University of Medical Sciences How to obtain: After the approval of the research vice-chancellor of Rafsanjan University of Medical Sciences, the data will be provided to the applicant. Comments:
public Fatemeh Jadidi
Moradi hospital, Shohada ST
Rafsanjan Iran (Islamic Republic of) 7713961151 +98 34 3426 0080 fa.jadidi.2020@gmail.com Rafsanjan University of Medical Sciences scientific Fatemeh Jadidi
Moradi hospital, Shohada ST
Rafsanjan Iran (Islamic Republic of) 7713961151 +98 34 3426 0080 fa.jadidi.2020@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) All subjects undergoing rhinoplasty surgery since the beginning of the study for 6 months 17-40 years 17 years 40 years Both Drug sensitivity to Dexmedetomidine and labetalol People with systolic blood pressure of 90 mmHg and lower People with a heart rate of less than 60 beats per minute upon entering the operating room R03.0 R00.8 T81.2 Elevated blood-pressure reading, without diagnosis of hypertension Other abnormalities of heart beat Accidental puncture and laceration during a procedure, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine in the form of a vial of 200 micrograms in 2 cc has a sympatholytic effect and is used as an infusion at a dose of 1 microgram per kilogram of body weight in 100 cc of normal saline to induce controlled hypotension during anesthesia according to the patient's needs. Intervention group:Labetalol vial 20 cc contains 5 mg in each cc and is an alpha and beta adrenergic blocker and causes blood pressure reduction with the mechanism of reducing peripheral vascular resistance while preventing the reflex increase of heart rate. It is a fast-acting drug that reaches its peak effect within 5 minutes. It is used in divided doses of 5 mg/cc, maximum 20 mg during anesthesia for one and a half to two hours according to the patient's needs for controlled hypotension. Systolic blood pressure. Timepoint: Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery,. Method of measurement: Mercury sphygmomanometer. Diastolic blood pressure. Timepoint: Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery. Method of measurement: Mercury sphygmomanometer. Heart rate. Timepoint: Before the start of surgery, after intubation, 20 minutes after intubation, during osteotomy, at the end of surgery, in recovery. Method of measurement: Pulse oximeter. Bleeding rate. Timepoint: During osteotomy, at the end of surgery. Method of measurement: The difference in the weight of the consumed substances will be used to check the amount of bleeding. (weight of sterile gases after use + weight of suctioned liquids during surgery) - (weight of dry gases before use + amount of normal saline serum for washing the surgical site). Rafsanjan University of Medical Sciences Approved 2022-06-01 Ethics committee of Rafsanjan University of Medical Sciences Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)