Impact of Preoperative Midazolam on Outcome of Elderly Patients

Summary

We aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction

Timeline

Start

2017-10-12

Primary completion

2019-06-24

Completion

2019-06-24

Outcome

Missed primary endpoint

paper The mean (SD) global index of patient satisfaction did not differ between the midazolam and placebo groups PMID 38117527 ↗

paper mean difference, -0.2; 95% CI, -1.9 to 1.6; P = .85 PMID 38117527 ↗

Publications

• Results Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.
• Results American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults. J Am Geriatr Soc. 2015 Jan;63(1):142-50. doi: 10.1111/jgs.13281. Epub 2014 Dec 12.
• Results Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
• Kowark A, Keszei AP, Schneider G, Pilge S, Schneider F, Obert DP, Georgii MT, Heim M, Rossaint R, Ziemann S, van Waesberghe J, Czaplik M, Puhringer FK, Minarski C, May V, Malisi T, Drexler B, Ring CM, Engler P, Tilly R, Bischoff P, Frey U, Wittmann M, Soehle M, Saller T, Kienbaum P, Kretzschmar M, Coburn M; I-PROMOTE Study Group. Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial. JAMA Surg. 2024 Feb 1;159(2):129-138. doi: 10.1001/jamasurg.2023.6479.
• Wang ML, Min J, Sands LP, Leung JM; the Perioperative Medicine Research Group. Midazolam Premedication Immediately Before Surgery Is Not Associated With Early Postoperative Delirium. Anesth Analg. 2021 Sep 1;133(3):765-771. doi: 10.1213/ANE.0000000000005482.
• Kowark A, Rossaint R, Keszei AP, Bischoff P, Czaplik M, Drexler B, Kienbaum P, Kretzschmar M, Rex C, Saller T, Schneider G, Soehle M, Coburn M; I-PROMOTE study group. Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial. Trials. 2019 Jul 15;20(1):430. doi: 10.1186/s13063-019-3512-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	3.75 mg	Oral

Indications

No indication recorded.