Impact of PReOperative Midazolam on OuTcome of Elderly Patients (I-PROMOTE): Study Protocol for a Multicentre Randomised Controlled Trial

IntroductionPremedication 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.MethodsThis 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.DiscussionThis, 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.