Obesity due to excess calories
Conditions
Interventions
All patients will undergo the same procedures for monitoring, induction and maintenance of general anesthesia. It will require 140 patients in total divided into two groups: experimental and control.
Drug
Sponsors
Financiamento próprio.
Financiamento próprio.
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients included in the study protocol should meet the following criteria: age between 18 and 65 years; body mass index (BMI) > 40 kg / m2 regardless of the presence of comorbidities or BMI between 35 and 40 kg / m2 in the presence of comorbidities; framed in the ASA (American Society of Anaesthesiologists) from I to III; submitted to videolaparoscopic gastroplasty surgery under general anestesia; expected hospital stay of up to 36 hours.
Exclusion criteria
Exclusion criteria: It will be excluded from the study protocol the patients who: refuse to participate of the proposed study; have history of adverse reactions to any drug included in the study protocol; have history of alcohol or illicit substances abuse; are chronic users of opioids for various reasons; have hepatic or renal failure; need for conversion from laparoscopic surgery to laparotomy; concomitant surgical approach on other surgical site; have the presence of coexisting diseases that impair cognitive ability; have the presence of poorly controlled psychiatric illnesses; and have retarded neuropsychomotor development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Better quality of anesthesia recovery, verified by the global postoperative recovery score obtained through the QoR-40 questionnaire. The minimum significant difference between the groups should be at least 7 points in the overall score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of pain intensity presented by patients in the experimental group, assessed by numerical rating scale (NRS) of pain in four moments (T0, T1, T2 and T3) during the postoperative period. A reduction of at least 30% in pain scores is considered satisfactory.;Reduction of cumulative use of rescue opioids during the entire hospitalization period, evaluated through the administration record of medications present in the patient's prescription and medical records. A reduction of at least 30% is considered satisfactory.;Reduction of the incidence of adverse effects related to opioids, evaluated through report, anamnesis and examination of the patient during four moments in the postoperative period. The difference between the groups of the percentage of side effects will be submitted to hypothesis testing during data analysis;Reduction of the time for first ambulation after discharge from the surgical center, evaluated through a registry made by the physiotherapy team of the hospital. The difference between the groups will be submitted to hypothesis testing during data analysis.;Improvement of the quality of life of the patients in the experimental group after 3 months of the surgical intervention, evaluated through the quality of life score obtained by the SF-36 questionnaire. The difference of the score in each domain of the questionnaire between the groups will be submitted to hypothesis testing during data analysis. | — |
Countries
Brazil
Contacts
Public ContactClínica de Anestesia;João Paulo Santa Genoveva;Jordão Pontes
Complexo Hospitalar Santa Genoveva;Complexo Hospitalar Santa Genoveva
Outcome results
None listed