Comparison of dexmedetomidine and benzodiazepine for intraoperative sedation in elderly patients: a randomized clinical trial.

BACKGROUND AND OBJECTIVES: Elderly individuals have a greater sensitivity to sedation, and the most commonly used drugs for sedation are benzodiazepines, which exhibit some complication. Therefore, this study aimed to compare the use of dexmedetomidine and midazolam regarding proper sedation and postoperative complications in elderly individuals who require intraoperative sedation. METHODS: This study was a parallel-randomized clinical trial, which included 120 patients aged >70 years undergoing regional anesthesia and sedation. The exclusion criteria consisted of bradycardia, heart failure, respiratory failure, a Glasgow Coma Scale ≤14, liver failure and refusal to participate. Patients were divided into two groups: the first group received midazolam (MDZ), while the second group received dexmedetomidine (DEX). The doses were titrated to achieve an intraoperative Richmond Agitation-Sedation Scale (RASS) score between -3 and -1. Incidences of complications were recorded. RESULTS: During a 120 min follow-up, the depth of sedation (RASS score) revealed variations less often in the DEX group (p=0.002). Patients in the DEX group (n=67) had lower rates of intraoperative complications (19.4% vs 73.6%, p<0.001). Intraoperatively, the incidence rates of psychomotor agitation (15.1% vs 1.5%, p=0.005), arterial hypotension (28.3% vs 3.0%, p<0.001) and respiratory depression (73.6% vs 0%, p<0.001) were higher in the MDZ group (n=53). During postanesthesia care, the incidence rates of shivering (p<0.001), residual sedation (p=0.04) and use of supplemental oxygen (p<0.001) were significantly lower in the DEX group. CONCLUSIONS: The use of DEX for sedation during surgery provides better control over the depth of sedation and produces fewer complications in elderly individuals. TRIAL REGISTRATION NUMBER: NCT02878837.

Goal-directed therapy in patients with early acute kidney injury: a multicenter randomized controlled trial.

OBJECTIVES: Acute kidney injury is associated with many conditions, and no interventions to improve the outcomes of established acute kidney injury have been developed. We performed this study to determine whether goal-directed therapy conducted during the early stages of acute kidney injury could change the course of the disease. METHODS: This was a multicenter prospective randomized controlled study. Patients with early acute kidney injury in the critical care unit were randomly allocated to a standard care (control) group or a goal-directed therapy group with 8h of intensive treatment to maximize oxygen delivery, and all patients were evaluated during a period of 72h. ClinicalTrials.gov: NCT02414906. RESULTS: A total of 143 patients were eligible for the study, and 99 patients were randomized. Central venous oxygen saturation was significantly increased and the serum lactate level significantly was decreased from baseline levels in the goal-directed therapy group (p=0.001) compared to the control group (p=0.572). No significant differences in the change in serum creatinine level (p=0.96), persistence of acute kidney injury beyond 72h (p=0.064) or the need for renal replacement therapy (p=0.82) were observed between the two groups. In-hospital mortality was significantly lower in the goal-directed therapy group than in the control group (33% vs. 51%; RR: 0.61, 95% CI: 0.37-1.00, p=0.048, number needed to treat=5). CONCLUSIONS: Goal-directed therapy for patients in the early stages of acute kidney injury did not change the disease course.

Goal-directed therapy in patients with early acute kidney injury: a multicenter randomized controlled trial

OBJECTIVES: Acute kidney injury is associated with many conditions, and no interventions to improve the outcomes of established acute kidney injury have been developed. We performed this study to determine whether goal-directed therapy conducted during the early stages of acute kidney injury could change the course of the disease. METHODS: This was a multicenter prospective randomized controlled study. Patients with early acute kidney injury in the critical care unit were randomly allocated to a standard care (control) group or a goal-directed therapy group with 8h of intensive treatment to maximize oxygen delivery, and all patients were evaluated during a period of 72h. ClinicalTrials.gov: NCT02414906. RESULTS: A total of 143 patients were eligible for the study, and 99 patients were randomized. Central venous oxygen saturation was significantly increased and the serum lactate level significantly was decreased from baseline levels in the goal-directed therapy group (p=0.001) compared to the control group (p=0.572). No significant differences in the change in serum creatinine level (p=0.96), persistence of acute kidney injury beyond 72h (p=0.064) or the need for renal replacement therapy (p=0.82) were observed between the two groups. In-hospital mortality was significantly lower in the goal-directed therapy group than in the control group (33% vs. 51%; RR: 0.61, 95% CI: 0.37-1.00, p=0.048, number needed to treat=5). CONCLUSIONS: Goal-directed therapy for patients in the early stages of acute kidney injury did not change the disease course.