Preoperative Midazolam and Patient-Centered Outcomes of Older Patients
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Published:2023-12-20
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ISSN:2168-6254
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Container-title:JAMA Surgery
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language:en
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Short-container-title:JAMA Surg
Author:
Kowark Ana12, Keszei András P.3, Schneider Gerhard4, Pilge Stefanie4, Schneider Frederick4, Obert David P.4, Georgii Marie-Therese4, Heim Markus4, Rossaint Rolf2, Ziemann Sebastian2, van Waesberghe Julia2, Czaplik Michael2, Pühringer Friedrich K.5, Minarski Christian5, May Verena5, Malisi Tobias5, Drexler Berthold6, Ring Carmen Maria6, Engler Phillip67, Tilly Roman6, Bischoff Petra8, Frey Ulrich8, Wittmann Maria1, Soehle Martin1, Saller Thomas9, Kienbaum Peter10, Kretzschmar Moritz11, Coburn Mark1, Brenes Andres12, Ernst Leonie12, Feddersen Pia12, Kapfer Barbara12, Maluche Susanne12, Muggleton Ellis12, Schneider Michael12, Grüßer Linda12, Wallqvist Julia12, Heusel Anna12, Diepold Simon12, Rex Christopher12, Grundmann Carla12, Wischermann Jan12, Fingerhut Louise12, Neumann Claudia12, Guttenthaler Vera12, Briegel Josef12, Möhnle Patrick12, Lampert Catharina12, Sulot Tanja12,
Affiliation:
1. Department of Anaesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany 2. Department of Anesthesiology, Medical Faculty University Hospital RWTH Aachen, Aachen, Germany 3. Center for Translational & Clinical Research Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany 4. Department of Anesthesiology and Intensive Care, Technical University of Munich, School of Medicine, Munich, Germany 5. Department for Anaesthesiology, Intensive Care, Emergency Medicine, Pain Therapy and Palliative Care, Kreiskliniken Reutlingen, Reutlingen, Germany 6. Department of Anaesthesiology and Intensive Care, University Hospital Tübingen, Tübingen, Germany 7. Department of Radiology, University Hospital Tübingen, Tübingen, Germany 8. Department of Anaesthesiology, Surgical Intensive Care, Pain and Palliative Care, Marien Hospital Herne, University Hospital of Ruhr University Bochum, Herne, Germany 9. Department of Anaesthesiology, University Hospital, LMU Munich, Munich, Germany 10. Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany 11. Department of Anaesthesiology and Intensive Care Medicine, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany 12. for the I-PROMOTE Study Group
Abstract
ImportanceThe effect of oral midazolam premedication on patient satisfaction in older patients undergoing surgery is unclear, despite its widespread use.ObjectiveTo determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo.Design, Setting, and ParticipantsThis 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.InterventionsPatients 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 MeasuresThe 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.ResultsAmong 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 RelevanceA 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 RegistrationClinicalTrials.gov Identifier: NCT03052660
Publisher
American Medical Association (AMA)
Cited by
1 articles.
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