Postprocedural disorder of digestive system, unspecified
Conditions
Interventions
This is a randomized, double-blind, single-center clinical trial with prospective evaluation and parallel control. The study will be conducted at Onofre Lopes University Hospital, located in the city
Sponsors
Empresa Brasileira De Servicos Hospitalares
Hospital Universitário Onofre Lopes
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age from 18 years; both genders; American Society of Anesthesiology (ASA) I or II; elective oral and maxillofacial surgery with expected duration between 1h and 3h; signed Free and Informed Consent
Exclusion criteria
Exclusion criteria: Previous diagnosis of atrioventricular block; cardiovascular disease that compromises the use of beta-blockers; diagnosis of asthma or Chronic Obstructive Pulmonary Disease; regular use of opioids; patients with chronic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the esmolol group will demonstrate a better anesthetic recovery score, as measured by the QoR-15, compared with the remifentanil group, while maintaining equivalent intraoperative hemodynamic parameters (heart rate, mean arterial pressure, and vasopressor use) between the groups;To analyze whether esmolol has a better safety profile than remifentanil in the postoperative period of patients undergoing oral and maxillofacial surgeries, that is, a QoR-15 score non-inferior to remifentanil, in addition to a lower incidence of postoperative pain, nausea, and vomiting | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative and postoperative variables will be analyzed with the objective of assessing the performance of esmolol relative to remifentanil. In the intraoperative period, outcomes will include intraoperative bleeding, estimated as the total aspirated volume minus the volume of irrigation solution used, and time to extubation, defined as the interval in minutes between the end of the surgical procedure and extubation. Postoperative outcomes will include the incidence of postoperative nausea and vomiting (PONV), the intensity of immediate postoperative pain assessed using a numeric rating scale (0–10), and the need for supplemental analgesia within the first 24 hours. These outcomes will be used to determine whether esmolol provides superior clinical results compared with remifentanil;To evaluate whether patients in the Esmolol group demonstrate better hemodynamic control, with a lower incidence of bleeding, as well as a shorter extubation time compared to the opioid | — |
Countries
Brazil
Contacts
Public ContactPedro Sousa
Hospital Universitário Onofre Lopes
Outcome results
None listed