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IRCT20110712007013N19 IRCT 2017-12-17 Tabriz University of Medical Sciences Effect of positive end-expiratory pressure (PEEP) on patients intraoperative respiratory status Effect of different levels of positive end-expiratory pressure (PEEP) on respiratory status during gynecologic laparoscopy 2017-08-23 anticipated 36 Complete https://irct.ir/trial/28041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization method used to randomly allocation of patients to study groups, Blinding description: In present study, patients, investigator, care provider, outcome assessor and data analyzer are blinded to participants study groups. The study team includes an anesthesiologists, who is responsible for data collection and outcome assessing, who is not in charge of anesthesia management, thus is not aware of interventions and study group. In addition, all study groups and subsequent interventions will be introduced to the patients and it will been mentioned in the written consent that patients will be blinded to the study groups and interventions. 2-3 Hemodynamic changes during gynecological surgery. Intervention 1: Control group: 12 patients will recieve zero end-expiratory pressure, in addition to PPV. Intervention 2: Intervention group: Intervention group: 12 patients will receive PEEP with pressure of 5 cmH2O, in addition to PPV. Intervention 3: Intervention group: 12 patients will receive PEEP with pressure of 10 cmH2O, in addition to PPV. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be shared. When: Th data will be available for 1 year, starting 3 months after publication. To whom: The data will be available only for academic institutions. Conditions: Not decided. Where to obtain: atashkhoii@tbzmed.ac.ir How to obtain: In order to acquire study data, the applicants should send an email containing their purpose and sufficient information about their work. Comments:
public Dr. Simin Atashkhoyi
Basghshomal coss road
Tabriz Iran (Islamic Republic of) 5183915881 +98 41 3553 9161 atashkhoii@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Simin Atashkhoyi
Baghshomal crossroad
Tabriz Iran (Islamic Republic of) 5183915881 +98 41 3553 9161 atashkhoii@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) American society of Anesthesiology (ASA) class I aged between 18-60 years old candidate for laparoscopic gynecological surgery interest to participate in study 18 years 60 years Female patients with ASA class II or higher not inclined to take part in study body mass index greater than 30 kg/m2 systemic disorders psychotic disorders emergent surgery smokers history of atopic disorders I97 Postprocedural disorders of circulatory system, not elsewhere classified Other Treatment - Other Treatment - Other Control group: 12 patients will recieve zero end-expiratory pressure, in addition to PPV. Intervention group: Intervention group: 12 patients will receive PEEP with pressure of 5 cmH2O, in addition to PPV. Intervention group: 12 patients will receive PEEP with pressure of 10 cmH2O, in addition to PPV. Heart Rate. Timepoint: before induction of anesthesia, immediately after induction, at 5th,10th, 20th, 30th, 60th minutes and at the end of operation. Method of measurement: Questionnaire. Systolic blood pressure. Timepoint: before induction of anesthesia, immediately after induction, at 5th,10th, 20th, 30th, 60th minutes and at the end of operation. Method of measurement: Monitor sphygmomonometer. Dyastolic blood pressure. Timepoint: before induction of anesthesia, immediately after induction, at 5th,10th, 20th, 30th, 60th minutes and at the end of operation. Method of measurement: Monitor sphygmomonometer. Arterial blood oxygen saturation. Timepoint: before induction of anesthesia, immediately after induction, at 5th,10th, 20th, 30th, 60th minutes and at the end of operation. Method of measurement: Monitor pulseoximeter. Urinary output volume. Timepoint: At the end of operation. Method of measurement: Urine bag. Blood loss volume. Timepoint: At the end of operation. Method of measurement: Suction device tank. Tabriz University of Medical Sciences Approved 2017-01-15 Ethics committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)