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A prospective randomised pilot study of sedation regimens in a general ICU population: a reality-based medicine study

Metadata Updated: September 6, 2025

Background: For logistical reasons sedation studies are often carried out in elective surgical patients and the results extrapolated to the general intensive care unit (ICU) population. We question the validity of this approach. We compared the two sedation regimens used in our general ICU in a trial structured to mimic clinical practice as closely as possible.

      Results:
      Forty patients were randomised to intermittent diazepam or continuous midazolam and sedation monitored with hourly sedation scores; 31 patients completed the study. Scores indicating undersedation were more common with diazepam (P <0.01); overall adequate sedation midazolam 64.7%, diazepam 35.7% (P =0.21). No patient exhibited inappropriately prolonged sedation. Cost was: midazolam AUS$1.98/h; diazepam AUS$0.06/h.


      Conclusion:
      Both regimens produced rapid onset of acceptable sedation but undersedation appeared more common with the cheaper diazepam regimen. At least 140 patients should be studied to provide evidence applicable to the general ICU population. Used alone, a sedation score may be an inappropriate outcome measure for a sedation trial.

Access & Use Information

Public: This dataset is intended for public access and use. License: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

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Dates

Metadata Created Date July 24, 2025
Metadata Updated Date September 6, 2025

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date July 24, 2025
Metadata Updated Date September 6, 2025
Publisher National Institutes of Health
Maintainer
NIH
Identifier https://healthdata.gov/api/views/dgi7-caej
Data First Published 2025-07-13
Data Last Modified 2025-09-06
Category NIH
Public Access Level public
Bureau Code 009:25
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id 93c0591c-991b-467c-9f45-250adf0315f8
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://healthdata.gov/d/dgi7-caej
Program Code 009:032
Source Datajson Identifier True
Source Hash f5fd4062187cbf02439d69adb014c3661880293b1123804af694139148c471b0
Source Schema Version 1.1

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