Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial

Abstract

Introduction Premedication with benzodiazepines in surgical patients became questionable regarding risk-benefit ratio and lack of evidence. Though, preoperative benzodiazepines might alleviate preoperative anxiety, a higher risk for adverse events is described, particularly for elderly patients (≥65 years). Several German hospitals already withhold benzodiazepine premedication from elderly patients, though evidence is lacking. The patient-centred outcome global postoperative patient satisfaction is recognized as a substantial quality indicator of the anaesthesia care incorporated by the American Society of Anesthesiologists. Therefore, we aim to assess, whether the postoperative patient satisfaction after premedication with placebo compared to the preoperative administration of 3.75 mg midazolam in elderly patients differs. Methods This study is a multicentre, randomised, placebo-controlled, double-blinded, two-arm parallel, interventional trial, conducted in 9 German hospitals. In total 614 patients (≥65-80 years of age) undergoing elective surgery with general anaesthesia will be randomised to receive either 3.75 mg midazolam or placebo. The primary outcome (global patient satisfaction) will be assessed with the validated EVAN-G questionnaire on the first postoperative day. Secondary outcomes will be assessed until the first postoperative day and 30 days after surgery, respectively. They comprise among others: functional and cognitive recovery, postoperative delirium, health-related quality of life assessment, and mortality or new-onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury. Analysis will adhere to the intention-to-treat principle. The primary outcome will be analysed with the use of mixed linear model including treatment effect and study centre as factors and random effects for blocks. Exploratory adjusted and subgroup analyses of the primary and secondary outcomes with regard to gender effects, frailty, pre-operative anxiety level, patient demographics and surgery experience will be performed in addition. Discussion This, to the best of our knowledge, is the first study analyzing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high quality data for decision-making process regarding premedication in the elderly surgical patients.

Developing a nomogram for predicting patients’ 24h-fatigue after digestive endoscopy with anesthesia assistance: a cross-sectional study

“…APAIS comprises 6 items, including four anxiety-related items and two information-demand items, designed to be easily comprehensible and quickly answerable. Moreover, the scale is well-recognized by both patients and doctors [27] . The researcher evaluated preoperative anxiety levels of patients when they were waiting their endoscopy procedure.…”

Evaluation of the safety and effects of pregabalin premedication on sleep quality, haemodynamic changes and pain in elderly patients with comorbidities undergoing spinal stenosis

“…Stress and anxiety due to possible elective surgery cause a series of metabolic and hormonal changes in elderly patients (the pituitary-hypothalamic-adrenocortical system is stimulated, and the sympatho-adrenal pathway is activated) [2], resulting in an increase (up to 40%) in the level of adrenaline [3]. Increased blood pressure and heart rate mean anaesthesia errors.…”

Perioperative benzodiazepine administration among older surgical patients

“…9,10 Importantly, gaps remain in the available base of randomised evidence regarding potential adverse effects of perioperative benzodiazepines for older surgical patients, which may partially explain the incomplete adoption of guideline recommendations observed here. Results from a large multicentre randomised trials assessing the impact of midazolam premedication on outcomes in older surgical patients 5 and of the effects of intraoperative benzodiazepine use on delirium in cardiac anaesthesia 11 are pending; our findings of widespread use of these medications in this patient group provides important context for the interpretation of such work and highlights the importance of additional rigorous randomised trials to characterise the potential risks of these medications. Finally, for populations where available data suggest that the benefits of benzodiazepine administration are unlikely to outweigh potential risks, our results highlight opportunities to improve care through benzodiazepine de-adoption efforts.…”

“…1,2 Benzodiazepines have been associated with delirium, and guidelines from the American Geriatrics Society 3 and others 4 recommend minimisation of benzodiazepine exposure for older surgical patients. Although trials to better quantify the risks of benzodiazepine administration are ongoing, 5 individual health systems have initiated efforts to support guideline adherence via perioperative benzodiazepine de-adoption. 6,7 Nonetheless, little is known about current patterns of benzodiazepine administration to older adults during anaesthesia care for surgical procedures in the USA.…”