obesity due to excess calories
Conditions
Interventions
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 patien
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
Drug
Other
E02.095.465
Sponsors
Rede D'Or Sao Luiz S.A.
Laboratório de Investigação Pulmonar da Universidade Federal do Rio de Janeiro
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients with insulin; anti-inflammatory and / or immunosuppressive therapies; diagnosis of malignant disease; chronic kidney disease, with KDOQI greater than 3; chronic liver disease, with total serum protein less than 3 grams per deciliter and total bilirubin greater than 5 milligrams per deciliter; heart disease, with NYHA III or IV; obesity caused by endocrine disorder; patients with psychiatric illness that may interfere with the capacity for formal consent and compliance; persistent smoking associated with significant obstructive or restrictive lung disease, with vital capacity or forced expiratory volume in one second less than 50% of predicted value; alcohol dependence; pre-existing coagulation disorders; evident pulmonary or systemic infection, with clinically defined or increased C reactive protein above 5 milligrams per ml, leukocytosis greater than 10,000, or body temperature greater than 37 Celsius; presence of autoimmune diseases; participated in another randomized clinical trial in the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactGiselle Sousa
Laboratório de Investigação Pulmonar da Universidade Federal do Rio de Janeiro
Outcome results
None listed