Assessment of quality of anesthesia between two different combinations of anesthetics in outpatient procedures: a clinical trial
- Conditions
- Ambulatory Surgical Procedures
- Registration Number
- RBR-4m7cpb5
- Lead Sponsor
- Empresa Brasileira de Serviços Hospitalares - EBSERH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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