Evaluation of the interference in the immunity caused by anesthetics Sevoflurane versus Propofol in intraoperative obese patients (obesita): study protocol for a randomized clinical trial

INTERVENTION: 48 obese patients, candidates for videolaparoscopic bariatric surgery will be randomized to receive general anesthesia with either propofol or sevoflurane. According to the randomization of the patients, the maintenance of anesthesia will be performed with: Group 1: 24 patients, propofol 2‐4 nanograms / ml in a target‐controlled infusion pump with March pharmacokinetic model, using adjusted body weight aiming to maintain a suitable level of hypnosis, bispectral index between 40‐60; or Group 2: 24 patients, sevoflurane, approximately 1 minimum alveolar concentration. This anesthesia will last all the surgery, between 1 and a half hours to 2 hours on average, and patients will be followed for 24 hours. E02.095.465 E02.570.500.062 E03.155.197.197 E03.155.308 CONDITION: C18.654.726.500.700 E00‐E90 obesity due to excess calories; morbid obesity. ; E66.0 ; C18.654.726.500.700 PRIMARY OUTCOME: Expected outcome 1: Plasma IL‐6 levels obtained from patients anesthetized with sevoflurane versus patients anesthetized with propofol in blood samples collected immediately before anesthetic induction and just prior to awakening.; According to similar studies, a change in effect size of 33% is expected after venous infusion of Propofol. SECONDARY OUTCOME: Expected outcome 2: The levels of inflammatory mediators obtained from blood samples collected immediately after anesthetic induction and immediately before awakening and of subcutaneous and visceral adipose tissue obtained immediately after performing gastroplasty of obese patients undergoing bariatric surgery under general anesthesia anesthetized with sevoflurane and propofol. Of Neutrophils: Metalloprotease 2, metalloprotease 9, CXCR2, IL‐12, CCL3, CCL2, IL‐1beta, TNF‐alpha, NRF2. Cell death pathways bax, bcl2, caspase 3 and caspase 9. ; Expected outcome 3: The levels of inflammatory mediators obtained from blood samples collected immediately after anesthetic induction and immediately before awakening and of subcutaneous and visceral adipose tissue obtained immediately after performing gastroplasty of obese patients undergoing bariatric surgery under general anesthesia anesthetized with sevoflurane and propofol. ; Of Macrophages: Pro‐inflammatories: IL‐6, IL‐1beta, TNF‐alpha, iNOS, CD40, CD80, ICAM‐1. Anti‐inflammatories: CD163, CD206, arginase, IL‐10, IL‐1RA, TGF‐beta1; NRF2. Cell death pathways: bax, bcl2, caspase 3 and caspase 9. INCLUSION CRITERIA: Age range 18 to 59 years; body mass index greater than or equal to 35 kilograms per square meter; signature of the free and informed consent form.