Assessment of quality of anesthesia between two different combinations of anesthetics in outpatient procedures: a clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: D03.383.129.308.245 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 computer randomization: propofol‐fentanyl (PF) group and propofol‐dexmedetomidine (PDex) group, allocated placed in a sealed envelope with the responsible person not involved with the research and another responsible person not involved with the research prepares the anesthetic solution corresponding to the allocated group; 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. CONDITION: Ambulatory Surgical Procedures PRIMARY OUTCOME: 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: 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 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
Epistemonikos ID: 8b04a5b4940775230b8e5fbe0cff1edca777bc9b
First added on: Feb 20, 2024