Ambulatory Surgical Procedures
Conditions
Interventions
Parallel Clinical Trial to compare group PF: Anesthesia with propofol associated with fentanyl with group PDex: Anesthesia with propofol associated with dexmedetomidine
participants randomly selected on specific days, according to the occurrence of procedures in the various specialties, randomized into two groups of 63 patients (total sample 126) each through control
triple-blind study
solution prepared as follows: Group PF: 1 g.Kg-1 of fentanyl in 100ml of saline solution, Group PDex: 0.5 g.Kg-1 of dexmedetomidine in 100ml of saline solution.
Sponsors
Empresa Brasileira de Serviços Hospitalares - EBSERH
Universidade Federal de Santa Catarina
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adult patients; aged between 18 and 65 years; undergoing elective outpatient surgical procedures with sedation performed by an anesthesiologist; procedures should be localized and restricted to the skin and subcutaneous tissue; with an expected duration of between 15 minutes and 1 hour; with ASA classification I to IV; who agreed to participate in the study
Exclusion criteria
Exclusion criteria: Illiterate patients; with some degree of cognitive or mental dysfunction; neurological disease; with a history of allergy to the study drugs; abuse of alcohol and/or illicit drugs or with alterations in renal and/or hepatic function; patients with chronic pain; use of antipsychotic drugs; alpha or beta blockers and/or opioids or who have severe cardiac pathology such as unstable angina; acute myocardial infarction in the last 6 months; heart rate < 50 bpm and systolic blood pressure of 90mmHg; block third-degree atrioventricular or pacemaker; in case of clinical need to use any other medication outside the study protocol or conversion from sedation to general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the quality of anesthesia through the degree of satisfaction of patients undergoing ambulatory surgical procedures under sedation with propofol associated with dexmedetomidine compared to propofol associated with fentanyl. Dexmedetomidine is expected to be a suitable drug for combination with propofol and to show good satisfaction for patients evaluated by the Iowa satisfaction scale, which is an anesthesia satisfaction score | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe the sociodemographic characteristics of the study population. Analyze hemodynamic and respiratory variables and identify adverse drug events, by measuring vital signs. Measure post-anesthetic recovery time. Check the incidence of nausea and vomiting in recovery. Quantify the dose of propofol used in each of the drug associations. Estimate the adequacy of sedation from the surgeon's perspective, by a visual scale. Identify factors and sociodemographic characteristics related to patient satisfaction, por meio do escore da escala de satisfação de Iowa | — |
Countries
Brazil
Contacts
Public ContactNicole Moritz
Empresa Brasileira de Serviços Hospitalares - EBSERH
Outcome results
None listed