Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial.

Importance: The effect of oral midazolam premedication on patient satisfaction in older patients undergoing surgery is unclear, despite its widespread use. Objective: To determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted in 9 German hospitals between October 2017 and May 2019 (last follow-up, June 24, 2019). Eligible patients aged 65 to 80 years who were scheduled for elective inpatient surgery for at least 30 minutes under general anesthesia and with planned extubation were enrolled. Data were analyzed from November 2019 to December 2020. Interventions: Patients were randomized to receive oral midazolam, 3.75 mg (n = 309), or placebo (n = 307) 30 to 45 minutes prior to anesthesia induction. Main Outcomes and Measures: The primary outcome was global patient satisfaction evaluated using the self-reported Evaluation du Vécu de l'Anesthésie Generale (EVAN-G) questionnaire on the first postoperative day. Key secondary outcomes included sensitivity and subgroup analyses of the primary outcome, perioperative patient vital data, adverse events, serious complications, and cognitive and functional recovery up to 30 days postoperatively. Results: Among 616 randomized patients, 607 were included in the primary analysis. Of these, 377 (62.1%) were male, and the mean (SD) age was 71.9 (4.4) years. The mean (SD) global index of patient satisfaction did not differ between the midazolam and placebo groups (69.5 [10.7] vs 69.6 [10.8], respectively; mean difference, -0.2; 95% CI, -1.9 to 1.6; P = .85). Sensitivity (per-protocol population, multiple imputation) and subgroup analyses (anxiety, frailty, sex, and previous surgical experience) did not alter the primary results. Secondary outcomes did not differ, except for a higher proportion of patients with hypertension (systolic blood pressure ≥160 mm Hg) at anesthesia induction in the placebo group. Conclusion and Relevance: A single low dose of oral midazolam premedication did not alter the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety. These results may be affected by the low dose of oral midazolam. Further trials-including a wider population with commonplace low-dose intravenous midazolam and plasma level measurements-are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03052660.

Associated abdominal injuries do not influence quality of care in pelvic fractures-a multicenter cohort study from the German Pelvic Registry.

Background: Pelvic fractures are rare but serious injuries. The influence of a concomitant abdominal trauma on the time point of surgery and the quality of care regarding quality of reduction or the clinical course in pelvic injuries has not been investigated yet. Methods: We retrospectively analyzed the prospective consecutive cohort from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003-2017. Demographic, clinical, and operative parameters were recorded and compared for two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma). Results: 16.359 patients with pelvic injuries were treated during this period. 21.6% had a concomitant abdominal trauma. The mean age was 61.4 ± 23.5 years. Comparing the two groups, patients with a combination of pelvic and abdominal trauma were significantly younger (47.3 ± 22.0 vs. 70.5 ± 20.4 years; p < 0.001). Both, complication (21.9% vs. 9.9%; p < 0.001) and mortality (8.0% vs. 1.9%; p < 0.001) rates, were significantly higher.In the subgroup of acetabular fractures, the operation time was significantly longer in the group with the combined injury (198 ± 104 vs. 176 ± 81 min, p = 0.001). The grade of successful anatomic reduction of the acetabular fracture did not differ between the two groups. Conclusion: Patients with a pelvic injury have a concomitant abdominal trauma in about 20% of the cases. The clinical course is significantly prolonged in patients with a combined injury, with increased rates of morbidity and mortality. However, the quality of the reduction in the subgroup of acetabular fractures is not influenced by a concomitant abdominal injury. Trial registration: ClinicalTrials.gov, NCT03952026, Registered 16 May 2019, retrospectively registered.

[Quality of operative treatment of pelvic fractures is not influenced by an additional abdominal injury : A monocentric registry study]. / Die Qualität der operativen Versorgung von Beckenfrakturen wird durch eine zusätzliche Abdominalverletzung nicht beeinflusst : Eine monozentrische Registerstudie.

BACKGROUND: Pelvic fractures are rare but severe injuries. The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters, such as reduction quality and the clinical course in pelvic injuries has not yet been sufficiently investigated. METHODS: This study retrospectively analyzed the prospective consecutive data of patients with pelvic injuries treated at the BG Trauma Center in Tübingen in the years 2003-2017. Demographic, clinical and operative parameters were recorded and compared between two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma). RESULTS: A total of 1848 patients with pelvic injuries were treated during this period and 18.6% had a concomitant abdominal trauma. The mean age was 62.3 ± 23.1 years. Comparing the two groups, patients with a combination of pelvic and abdominal trauma were significantly younger (46.3 ± 20.3 years vs. 70.6 ± 20.8 years; p < 0.001). Both the overall complication rate (31.2% vs. 9.4%; p < 0.001) and mortality (5.0% vs. 1.7%; p = 0.001) were significantly higher in the group with a combination of injuries. The time until definitive surgery of the pelvis was significantly longer in the group with combined injuries (6.0 ± 6.4 days vs. 4.5 ± 4.4 days; p = 0.002). The results of postoperative reduction did not differ between the two groups. CONCLUSION: Patients with a pelvic injuries have a concomitant abdominal trauma in approximately 20% of the cases. The clinical course is significantly prolonged in patients with a combined injury and morbidity and mortality rates are increased; however, the quality of the postoperative results is not influenced by a concomitant abdominal injury.

EASY (endoscopic approach to the symphysis): a new minimally invasive approach for the plate osteosynthesis of the symphysis and the anterior pelvic ring-a cadaver study and first clinical results.

BACKGROUND: Minimally invasive surgical approaches to reduce approach-associated morbidity are an interdisciplinary goal in surgery. In principle, the endoscopic approach for the extraperitoneal repair of groin hernias is the minimally invasive variant of the modified Stoppa-approach, which is used for the treatment of pelvic ring injuries in traumatology. METHOD: Anatomical feasibility study regarding the plate osteosynthesis of the anterior pelvic ring via a minimally invasive variant of the modified Stoppa-approach. RESULTS: We present the minimally invasive variant of the modified Stoppa-approach in a human cadaver step by step, both photographically and radiologically. Feasibility of the plate osteosynthesis of the symphysis is presented in a patient with open book injury via the minimally invasive approach using standard laparoscopic instruments. CONCLUSION: The plate osteosynthesis of the anterior pelvic ring via the minimally invasive variant of the modified Stoppa-approach is feasible with existing standard laparoscopic instruments.

Endoscopic Approach to the Quadrilateral Plate (EAQUAL): a New Endoscopic Approach for Plate Osteosynthesis of the Pelvic Ring and Acetabulum - a Cadaver Study. / Endoscopic Approach to the Quadrilateral Plate (EAQUAL): ein neuer endoskopischer Zugang für die Plattenosteosynthese des Beckenringes und Azetabulums ­ eine anatomische Machbarkeitsstudie.

BACKGROUND: Dislocated pelvic fractures which require surgical repair are usually operated on via open surgery. Approach-related morbidity is reported with a frequency of up to 30%. The aim of this anatomical study was to prove the feasibility of endoscopic visualisation of the relevant anatomical structures in pelvic surgery and to perform completely endoscopic plate osteosynthesis of the acetabulum with available standard laparoscopic instruments. METHOD: In four human cadavers, we established an endoscopic preparation of the complete pelvic ring, from the symphysis to the iliosacral joint, including the quadrilateral plate and the sciatic nerve, and performed endoscopic plate osteosynthesis along the iliopectineal line. RESULTS: The endoscopic preparation of the complete pelvic ring and the quadrilateral plate was demonstrated step-by-step, followed by completely endoscopic plate osteosynthesis along the pelvic brim. Endoscopic, radiographic, and schematic pictures are used to illustrate the technique. CONCLUSION: The completely endoscopic preparation of the pelvic brim and the quadrilateral plate is feasible with available standard laparoscopic instruments. Moreover, plate osteosynthesis could be performed endoscopically. Further research on reduction techniques is necessary when planning to implement this technique into a clinical scenario.