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IRCT20210508051226N1 IRCT 2022-10-25 Tehran University of Medical Sciences Fluid therapy in plastic surgery Evaluation of Goal Directed Fluid Therapy (GDFT) through Pleth Variability Index(PVI) in Plastic Surgery based on Enhanced Recovery After Surgery(ERAS) 2022-10-22 anticipated 72 Complete https://irct.ir/trial/56146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is based on blocking quadruple numbers. Variable blocks will be used for randomization, which is due to the ease of execution and the balance in the number of groups. In this way, the samples will be divided into A and B, and there will be six cases for the four blocks and the cards are replaced based on the number of samples, Blinding description: Blinding in this study is a two-way blind type. In this way, all the patients included in the study are unaware of being in the control or intervention arm (blind). On the other hand, the outcome assessor (primary and secondary) and the data analyzer They are blinded to the intervention and control groups. Due to the sensitivity of patient care during surgery and the absence of harm to the patients, the clinical caregiver (researcher) was not blinded to the intervention. N/A Plastic and cosmetic surgeries such as abdominoplasty, mammoplasty and lift. Intervention 1: Intervention group:36 patients are done fluid therapy (GDFT) based on PVI index. These patients are hospitalized the night before the operation and will be allowed to consume solid food 6 hours before the operation and clear and carbohydrate-rich liquids 2 hours before the operation. Fluid therapy in this group is prescribed based on the information obtained from the PVI with The goal is to keep the index under 13%. After transferring the patients to the surgical department, the patients in terms of the number of times they experienced nausea, vomiting, fever, constipation, the duration of fasting after the operation, the amount of receiving painkillers and antiemetics, the length of hospitalization Willingness to early discharge, surgical site infection, dehiscence, wound SSI, creatinine levels before or after surgery to check kidney function and pulmonary complications will be evaluated and the information will be entered into the questionnaire. Intervention 2: Control group: 36 patients, which includes the group of patients whose fluid therapy is traditional, in this group, pre-operative fluid therapy will be such that the patient is hospitalized one night before the operation and receives one liter of serum, and the patient 8 hours before He becomes NPO from the operation. In this group, fluid therapy during the operation is 4cc/Kg/h and the patient is NPO after the operation until full consciousness. Yes - There is a plan to make this available What will be shared: SPSS data file that includes demographic information, primary outcome and secondary outcomes When: Immediately after the publication of the article To whom: Academic and scientific researchers Conditions: Allowance of any analysis for the data Where to obtain: corresponding author How to obtain: E-mailing the corresponding author Comments:
public Nazli Ebrahimian
Sina hospital,Hassan abad sq.,Emam Khomeini st
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 Nazli.ebrahimian@gmail.com Tehran University of Medical Sciences scientific Nazli Ebrahimian
Sina hospital,Hassan abad sq.,Emam Khomeini st
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 Nazli.ebrahimian@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) With no history of specific diseases that are referred for plastic and cosmetic surgeries such as abdominoplasty, mammoplasty and lift 18 years 70 years Both Surgeries other than cosmetics and plastic surgery Outpatient cosmetic surgeries History of heart disease (cardiac arrhythmia, cardiac ejection fraction ≤30%) History of lung disease interfering with mechanical ventilation History of chronic kidney failure Z41.1 Other plastic surgery for unacceptable cosmetic appearance Treatment - Surgery Treatment - Surgery Intervention group:36 patients are done fluid therapy (GDFT) based on PVI index. These patients are hospitalized the night before the operation and will be allowed to consume solid food 6 hours before the operation and clear and carbohydrate-rich liquids 2 hours before the operation. Fluid therapy in this group is prescribed based on the information obtained from the PVI with The goal is to keep the index under 13%. After transferring the patients to the surgical department, the patients in terms of the number of times they experienced nausea, vomiting, fever, constipation, the duration of fasting after the operation, the amount of receiving painkillers and antiemetics, the length of hospitalization Willingness to early discharge, surgical site infection, dehiscence, wound SSI, creatinine levels before or after surgery to check kidney function and pulmonary complications will be evaluated and the information will be entered into the questionnaire. Control group: 36 patients, which includes the group of patients whose fluid therapy is traditional, in this group, pre-operative fluid therapy will be such that the patient is hospitalized one night before the operation and receives one liter of serum, and the patient 8 hours before He becomes NPO from the operation. In this group, fluid therapy during the operation is 4cc/Kg/h and the patient is NPO after the operation until full consciousness. Comparison of targeted fluid therapy (GDFT) through Plethysmographic Variability Index (PVI) in plastic surgeries based on rapid recovery protocol for patients after surgery (ERAS). Timepoint: during surgery period. Method of measurement: Through plethysmographic variability index (PVI) using pulse oximeter. Pain severity. Timepoint: daily after surgery. Method of measurement: Visual Analogue Score. Post operative nausea and vomiting. Timepoint: daily after surgery. Method of measurement: Questionnaire. Surgical site infection. Timepoint: Day 1-3-7-28 after surgery. Method of measurement: physician observation. Drowsiness and fatigue. Timepoint: daily after surgery. Method of measurement: Questionnaire. Constipation. Timepoint: daily after surgery. Method of measurement: questionnaire. Renal function. Timepoint: day 1-2 afyter surgery. Method of measurement: measuring serum creatinine. Pulmonary function. Timepoint: daily after surgery. Method of measurement: Questionnaire. Desire for early discharge. Timepoint: after surgery. Method of measurement: Questionnaire. Wound dehiscence. Timepoint: daily after surgery. Method of measurement: physician observation. Tehran University of Medical Sciences Approved 2021-04-21 sina hospital ethic committee sina hospital, hassanabad square imam khomeini street Tehran Tehran Iran (Islamic Republic of)