Morbid Obesity
Conditions
Interventions
All patients will be randomly distributed, using specific software, into 2 groups: experimental (group E) represented by opioid-free anesthesia and control (group C) represented by opioid-based anesth
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Sponsors
Complexo Hospitalar Santa Genoveva
Complexo Hospitalar Santa Genoveva
Eligibility
Age
No minimum to 65 Years
Inclusion criteria
Inclusion criteria: Patients included in the study protocol must meet the following prerequisites: age between 18 and 65 years; with a Body Mass Index (BMI) higher than 40 kg/m2 regardless of the presence of comorbidities or a BMI between 35 and 39.9 kg/ m2 in the presence of comorbidities; classified in the physical status ASA (American Society of Anaesthesiologists) of II or III; patients undergoing laparoscopic gastroplasty surgery under general anesthesia; expected hospital stay of up to 36 hours.
Exclusion criteria
Exclusion criteria: Patients who refuse to participate in the proposed study; patients who are younger than 18 and older than 65 years; who have a BMI (body mass index) lower than 35 kg/m2 or a BMI between 35 and 40 kg/m2 without comorbidities; patients who report adverse reactions to any drug included in the study; patients who have a history of alcohol or illicit substance abuse or chronic use of opioids for various reasons; patients who report liver or kidney failure; patients who have coexisting diseases that impair cognitive ability, such as poorly controlled psychiatric illnesses or neuropsychomotor developmental delay.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the assessment of the incidence of composite opioid-related adverse effects in the first hours after extubation and during hospitalization. The components of the composition will be nausea and vomiting, hypoxemia, defined as Sp02 below 90% with need for supplemental oxygen, and sedation, defined as a score greater or equal to 2 on the Wilson scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bradycardia incidence (Heart rate less than 40 bpm);Arterial Hypotension (Mean arterial pressure less than 60 mmHg);Postoperative nausea and vomiting incidence (PONV);Postanestia care unit lenght of stay ;Hypoxemia incidence (SatO2 less than 90%);Pain burden;Pain intensity through verbal numeric rating scale (NRS);Rescue opioid consumption;Patient satisfaction through numeric verbal scale;Quality of Recovery using QoR-15 questionnaire | — |
Countries
Brazil
Contacts
Public ContactSanta Genoveva Complexo Hospitalar
Complexo Hospitalar Santa Genoveva
Outcome results
None listed