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IRCT20101026005026N13 IRCT 2022-01-30 Iran University of Medical Sciences The effect of respiratory system on reducing bleeding in rhinoplasty surgery. Comprative evaluation of pressure control ventilation and volume control ventilation on intraoperative blood loss in rhinoplasty surgery . 2022-02-20 anticipated 30 Complete https://irct.ir/trial/61242 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of outcomes do not know about the treatment process and study groups, and information is provided to them in groups A and B. N/A Rhinoplasty. Intervention 1: Intervention group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the intervention group, patients are mechanically ventilated with a volume ventilation mode with a current volume of 7 ml per kg and a rate of respiration of 10 per minute and a ratio of inhalation to exhalation of 1: 2. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model. Intervention 2: Control group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the pressure ventilation group with pressure mode, patients are exposed to a respiratory pressure of 15 cm of water and 10 breaths per minute, and gradually the pressure changes to reach EtCO2 = 40-35. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model. 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 Masood Mohseni
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2326 mohseni@med.mui.ac.ir Iran University of Medical Sciences scientific Masood Mohseni
Rasul Akram hospital, Niayesh Ave, Sattarkhan St
Tehran Iran (Islamic Republic of) 1446513131 +98 21 6435 2326 mohseni@med.mui.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction Candidate for rhinoplasty surgery 18 years 50 years Both Pregnancy Body mass index higher than 35 Coagulation disorders Y81 General- and plastic-surgery devices associated with adverse incidents Treatment - Devices Treatment - Devices Intervention group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the intervention group, patients are mechanically ventilated with a volume ventilation mode with a current volume of 7 ml per kg and a rate of respiration of 10 per minute and a ratio of inhalation to exhalation of 1: 2. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model. Control group: First, a suitable venous line is taken and then premedication is prescribed. Induction of anesthesia of patients is performed by the same method in both groups. Then, the patients are intubated with a spiral tube made by Jahan Tajhiz Hakim Company and subjected to mechanical ventilation. In the pressure ventilation group with pressure mode, patients are exposed to a respiratory pressure of 15 cm of water and 10 breaths per minute, and gradually the pressure changes to reach EtCO2 = 40-35. All patients are operated on by a surgeon. During surgery, the patient's bleeding rate was checked by checking the number of blood-soaked gases and the content of the suction, the surgeon's satisfaction was measured using the Likert scale, and the bleeding in the surgical field was measured using the Boezaart criterion at the end of the operation. The anesthesia device used for respiratory ventilation is the Fabius plus SW 3.n model. Bleeding rate. Timepoint: During the surgery. Method of measurement: Number of blood gases and volume of blood inside the suction. Surgeon satisfaction. Timepoint: During the surgery. Method of measurement: Using the Likert scale. Blood pressure. Timepoint: During surgery. Method of measurement: Using monitor. Heart rate. Timepoint: During surgery. Method of measurement: Using monitor. Iran University of Medical Sciences Approved 2021-11-30 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)