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IRCT20230704058667N1 IRCT 2023-08-23 Shiraz University of Medical Sciences Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair Comparing the duration of CO۲ blowing into the surgical field during cardiac bypass on arterial carbon dioxide pressure in patients undergoing minimally invasive mitral valve repair 2023-09-01 anticipated 50 Complete https://irct.ir/trial/71280 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 4 and 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 10 blocks will be selected randomly and patients will be allocated randomly and equally into two groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com. 2-3 Mitral regurgitation. Intervention 1: Control group (first group): In this study, all anesthesia conditions and settings of the pump device and prime oxygenator protocol are the same for all patients. Also, the cardioplegia solution used in all patients is the same. Inminimally invasive mitral valve repair (Minithoracotomy), surgeons inject carbon dioxide gas throughout the procedure at a speed of 6 liters per minute, which increases the blood co2 level of patients during the bypass period. Intervention 2: Intervention group (second group): our purpose in this study is to prevent the increase of CO2 during cardiopulmonary bypass and also to reduce air embolism by changing the time of carbon dioxide gas injection in the chest cavity. In the patients of the second group, carbon dioxide injection is done only when rewarming the patient. With this timing, we try to reduce the related complications during cardiopulmonary bypass. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Mozhdeh Eskandari
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 1564471948 +98 36474270 mozhdeheskandari0@gmail.com Shiraz University of Medical Sciences scientific Ahmad Ali Amirghofran
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 1564471948 +98 36474270 amirghofranaa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) patients between 20 and 55 years old Patients who candidate for minimally invasive mitral valve repair Patients with normal pulmonary status 20 years 55 years Both Positive history of liver and kidney failure Positive history of Carotid artery stenosis Positive history of brain diseases Use of psychiatric medication Alcoholic patients I34.0 Nonrheumatic mitral (valve) insufficiency Treatment - Surgery Treatment - Surgery Control group (first group): In this study, all anesthesia conditions and settings of the pump device and prime oxygenator protocol are the same for all patients. Also, the cardioplegia solution used in all patients is the same. Inminimally invasive mitral valve repair (Minithoracotomy), surgeons inject carbon dioxide gas throughout the procedure at a speed of 6 liters per minute, which increases the blood co2 level of patients during the bypass period. Intervention group (second group): our purpose in this study is to prevent the increase of CO2 during cardiopulmonary bypass and also to reduce air embolism by changing the time of carbon dioxide gas injection in the chest cavity. In the patients of the second group, carbon dioxide injection is done only when rewarming the patient. With this timing, we try to reduce the related complications during cardiopulmonary bypass. Arterial carbon dioxide pressure. Timepoint: 10, 30, 60, 90 minutes after induction of anesthesia and day 1, 2, 3 of hospitalization in ICU. Method of measurement: Arterial blood pressure was measured using an arterial blood sample and a blood gas analyzer. Postoperative Delirium. Timepoint: first and 2nd postoperative day. Method of measurement: Delirium Screening Questionnaire (Nu-DESC). Shiraz University of Medical Sciences Approved 2023-06-10 Ethics Committee of Shiraz Medical School. 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)