Evaluation of Goal Directed Fluid Therapy (GDFT) through Pleth Variability Index(PVI) in Plastic Surgery based on Enhanced Recovery After Surgery(ERAS)

Comparison of Goal Directed fluid therapy (GDFT) through Plethysmographic Variability Index (PVI) in plastic surgeries based on the Accelerated Recovery of Patients After Surgery (ERAS) protocol.

A clinical trial with a control group, with parallel groups, randomized, on 72 patients

In patients undergoing surgery (abdominoplasty, mammoplasty) in the plastic department of Sina Hospital, comparing targeted fluid therapy based on the PVI index and the Traditional method, a double-blind randomized trial, in which the researcher and the patient were blinded.

Inclusion criteria: People over 18 years of age and without a history of specific diseases, who refer to Sinai Hospital for plastic and cosmetic surgeries such as abdominoplasty, mammoplasty, and facelift, will be included in the study. Exclusion criteria: people who are undergoing surgeries other than cosmetic or day care surgeries, patients under 18 years old, people with a history of underlying diseases, patients with cardiac arrhythmia, cardiac ejection fraction ≤30% , pulmonary diseases interfering with mechanical ventilation and patients with chronic kidney failure and patients who experience massive bleeding during surgery that requires blood transfusion, the duration of the operation will not be less than 2 hours will not be included in the study.

The intervention group (36 patients) includes targeted fluid therapy (GDFT) based on the PVI index with the aim of keeping the index below 13%. The control group (36 patients) includes patients whose fluid therapy is traditional during the operation (4cc/Kg/h).

effect of fluid therapy; pain; nausea and vomiting; fatigue and sleepiness; constipation; tendency to discharge; wound site infection; wound site dehisence comparing the intervention group with the control group

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 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.

SPSS data file that includes demographic information, primary outcome and secondary outcomes

Immediately after the publication of the article

Academic and scientific researchers

Allowance of any analysis for the data

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