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

Trials

I-PROMOTE study group¹  András P. Keszei²  Christopher Rex³  Moritz Kretzschmar⁴  Martin Soehle⁵  Berthold Drexler⁶  Michael Czaplik⁷  Ana Kowark⁷  Rolf Rossaint⁷  Mark Coburn⁷  Petra Bischoff⁸  Gerhard Schneider⁹  Peter Kienbaum^1,10  Thomas Saller^1,11 

[1] ;Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University;Department for Anaesthesiology, Intensive Care, Emergency Medicine, Pain Therapy and Palliative Care, Kreiskliniken Reutlingen;Department of Anaesthesiology and Intensive Care Medicine, Otto-von-Guericke-University Magdeburg;Department of Anaesthesiology and Intensive Care Medicine, University Hospital Bonn;Department of Anaesthesiology and Intensive Care, University Hospital Tübingen;Department of Anaesthesiology, Medical Faculty RWTH Aachen University;Department of Anaesthesiology, Surgical Intensive Care, Pain and Palliative Care, Marien Hospital Herne, University Hospital of Ruhr University Bochum;Department of Anaesthesiology, Technical University of Munich (TUM);Department of Anaesthesiology, University Hospital Düsseldorf;Department of Anaesthesiology, University Hospital, LMU Munich;

关键词: General anaesthesia;    Midazolam;    Patient satisfaction;    Placebo;    Premedication;   

DOI  :  10.1186/s13063-019-3512-3

来源: DOAJ

【 摘 要 】

Abstract Introduction Premedication of surgical patients with benzodiazepines has become 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 for this approach is lacking. The patient-centred outcome known as global postoperative patient satisfaction is recognised as a substantial quality indicator of 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 nine 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 then 30 days after surgery. They comprise among other things: 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 models 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 also be performed. Discussion This is, to the best of our knowledge, the first study analysing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high-quality data for the decision-making process regarding premedication in elderly surgical patients. Trial registration ClinicalTrials.gov, NCT03052660. Registered on 14 February 2017. EudraCT 2016-004555-79.

【 授权许可】

Unknown